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Product Catalog
Products by Category
At Ethicon, we develop meaningful solutions that enhance surgical outcomes and improve the lives of patients. For more than
80 years, we have listened to the voice of our customers, working in partnership with clinicians, hospitals, payors, and other
healthcare stakeholders to gain deep experience and perspective into ways to redefine surgery. Our global scope, along with
our broad surgical portfolio, let us provide market-appropriate, value-driven solutions that help patients around the world live
longer, healthier lives.
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Access
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Access
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Access
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ENDOPATH® Mini/Micro
Trocars Nonoptical Product Shaft Shaft
Sleeve EA/BX
2mm/3mm Code Diameter Length
Access
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FPK02 Contains: (1) 15mm obturator and (3) 15mm flexible sleeves 6
PN120 120mm 12
PN150 150mm 12
UV120 120mm 12
Adjunctive Hemostat
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SURGIFOAM® Absorbable
Gelatin Powder Product
Description EA/BX
Code
1978 1.0g 6
Adjunctive Hemostat
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1979 1.0g 6
1985 1.0g 12
Adjunctive Hemostat
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Advanced Energy
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Advanced Energy
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HARMONIC® Blades
Product Shaft Shaft
Tip EA/BX
Code Diameter Length
Advanced Energy
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HARMONIC® Accessories
Product
Description EA/BX
Code
Advanced Energy
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Advanced Energy
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ETHICON ENDO-SURGERY™
Generator Accessories Product
Description Compatible with EA/BX
Code
HARMONIC®
HGA11 HP054 and HPBLUE hand pieces 1
connector
ENSEAL® ENSEAL® Trio Tissue Sealer and
EGA11 1
connector ENSEAL® Round Tip Tissue Sealer
Output
GEN11VK verification GEN11 1
key
Foot switch
FSW11 GEN11 1
and cable
Generator
CRT11 GEN11 1
cart
HARMONIC® Accessories
Product
Description EA/BX
Code
Advanced Energy
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Advanced Energy
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HARMONIC® Blades
Product Shaft Shaft
Tip EA/BX
Code Diameter Length
Advanced Energy
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HARMONIC® Accessories
Product
Description EA/BX
Code
Advanced Energy
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Advanced Energy
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ETHICON GEN11 Generator Accessories
Product
Description Compatible with EA/BX
Code
HARMONIC®
HGA11 HP054 and HPBLUE hand pieces 1
connector
Output
GEN11VK GEN11 1
verification key
1-Year extended
GEN11WAR1 1
warranty
2-Year extended
GEN11WAR2 1
warranty
Energy
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MEGADYNE™ MEGA POWER™ Generator
Product Code Compatible with EA/BX
Energy
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MEGADYNE™ E-Z CLEAN™ Coated Blade
Electrodes Product Code Description Tip Length EA/BX
Energy
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MEGADYNE™ E-Z CLEAN™ Coated
Specialty Electrodes Product Code Description Tip Length EA/BX
Energy
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MEGADYNE™ E-Z CLEAN™ Protective
Nose Cone Electrodes Product Code Description Tip Length EA/BX
Energy
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MEGADYNE™ E-Z CLEAN™ Laparoscopic
Electrodes Product Tip
Compatible With Length EA/BX
Code Configuration
0600 L-Wire 6
0605 J-Wire 6
0618 Spatula 6
0620 L-Hook 6
0621 J-Hook 6
MEGADYNE™ Reusable
Foot Control Cord Product Code Description Length EA/BX
Energy
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MEGADYNE™ Rocker Switch Pencil
Cord
Product Code Description EA/BX
Length
Energy
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MEGADYNE™ MEGA SOFT™ Universal
Reusable Patient Return Electrode Electrodes Cables
Product Code Description
91cm x 51cm x 0.3cm per box per box
MEGA SOFT™ Universal with one M2K01
0845M2K01 1 1
cable: Standard connector, 2.4m length
MEGA SOFT™ Universal with one M2K02
0845M2K02 1 1
cable: Standard connector, 4.4m length
MEGA SOFT™ Universal with one M2K03
0845M2K03 1 1
cable: Phone plug connector, 2.4m length
MEGA SOFT™ Universal with one M2K04
0845M2K04 1 1
cable: Phone plug connector, 4.4m length
MEGA SOFT™ Universal with one M2K05
0845M2K05 cable: Extended phone plug connector, 1 1
4.4m length
MEGA SOFT™ Universal with one M2K06
0845M2K06 1 1
cable: Argon beam connector, 2.4m length
MEGA SOFT™ Universal with one M2K08
0845M2K08 1 1
cable: Compatibility cable, 2.4m length
MEGA SOFT™ Universal with one M2K09
0845M2K09 1 1
cable: Compatibility cable, 4.4m length
Energy
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MEGADYNE™ MEGA SOFT™ Universal
Dual Reusable Patient Return Electrode Electrodes Cables
Product Code Description
91cm x 50cm x 0.3175cm per box per box
MEGA SOFT™ Universal Dual with two
0846M2K01 M2K01 cables: Standard connector, 2.4m 1 2
length
MEGA SOFT™ Universal Dual with two
0846M2K02 M2K02 cables: Standard connector, 4.4m 1 2
length
MEGA SOFT™ Universal Dual with two
0846M2K03 M2K03 cables: Phone plug connector, 1 2
2.4m length
MEGA SOFT™ Universal Dual with two
0846M2K04 M2K04 cables: Phone plug connector, 1 2
4.4m length
MEGA SOFT™ Universal Dual with two
0846M2K05 M2K05 cables: Extended phone plug 1 2
connector, 4.4m length
MEGA SOFT™ Universal Dual with two
0846M2K06 M2K06 cables: Argon beam connector, 1 2
2.4m length
MEGA SOFT™ Universal Dual with two
0846M2K08 M2K08 cables: Compatibility cable, 2.4m 1 2
length
MEGA SOFT™ Universal Dual with two
0846M2K09 M2K09 cables: Compatibility cable, 4.4m 1 2
length
Energy
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MEGADYNE™ MEGA SOFT™ Reusable
Patient Return Electrode Electrodes Cables
Product Code Description
117cm x 51cm x 1.25cm per box per box
MEGA SOFT™ with one M2K01 cable:
0830M2K01 1 1
Standard connector, 2.4m length
MEGA SOFT™ with one M2K02 cable:
0830M2K02 1 1
Standard connector, 4.4m length
MEGA SOFT™ with one M2K03 cable:
0830M2K03 1 1
Phone plug connector, 2.4m length
MEGA SOFT™ with one M2K04 cable:
0830M2K04 1 1
Phone plug connector, 4.4m length
MEGA SOFT™ with one M2K05 cable:
0830M2K05 Extended phone plug connector, 4.4m 1 1
length
MEGA SOFT™ with one M2K06 cable:
0830M2K06 1 1
Argon beam connector, 2.4m length
MEGA SOFT™ with one M2K08 cable:
0830M2K08 1 1
Compatibility cable, 2.4m length
MEGA SOFT™ with one M2K09 cable:
0830M2K09 1 1
Compatibility cable, 4.4m length
Energy
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MEGADYNE™ MEGA SOFT™ Pediatric
Reusable Patient Return Electrode Electrodes Cables
Product Code Description
66cm x 30.5cm x 1.3cm per box per box
MEGA SOFT™ Pediatric with one M2K01
0840M2K01 1 1
cable: Standard connector, 2.4m length
MEGA SOFT™ Pediatric with one M2K02
0840M2K02 1 1
cable: Standard connector, 4.4m length
MEGA SOFT™ Pediatric with one M2K03
0840M2K03 1 1
cable: Phone plug connector, 2.4m length
MEGA SOFT™ Pediatric with one M2K04
0840M2K04 1 1
cable: Phone plug connector, 4.4m length
MEGA SOFT™ Pediatric with one M2K05
0840M2K05 cable: Extended phone plug connector, 1 1
4.4m length
MEGA SOFT™ Pediatric with one M2K06
0840M2K06 1 1
cable: Argon beam connector, 2.4m length
MEGA SOFT™ Pediatric with one M2K08
0840M2K08 1 1
cable: Compatibility cable, 2.4m length
MEGA SOFT™ Pediatric with one M2K09
0840M2K09 1 1
cable: Compatibility cable, 4.4m length
Energy
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MEGADYNE™ MEGA SOFT™ Reusable
Patient Return Electrode Product Code Description EA/BX
Energy
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MEGADYNE™ MINI VAC™ Smoke
Evacuators and Accessories Product Code Description EA/BX
Energy
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Smoke Evacuation Pencils and
Accessories Product Code Description EA/BX
Energy
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MEGADYNE™ Stainless Steel Blade
Electrodes Product Code Description Tip Length EA/BX
Energy
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MEGADYNE™ Disposable Patient Return
Electrodes and Accessories Cord
Product Code Description EA/BX
Length
Energy
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ENDOPATH® Electrosurgery
PROBE PLUS® II System Product Code Grip Control EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II Electrode Shafts Product Code Shaft Diameter Shaft Length Electrode EA/BX
ENDOPATH® Electrosurgery
PROBE PLUS® II Tubing Product Code Description EA/BX
Energy
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MEGADYNE™ All-In-One Hand
Control Unit Product Code Description EA/BX
Energy
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MEGADYNE™ LLETZ Loop Electrodes
Square Product Code Description Color EA/BX
ULTRAPRO® Partially
Absorbable Lightweight Mesh Product
Description Size EA/BX
Code
ULTRAPRO ADVANCED™
Product
Description Size EA/BX
Code
PROLENE® Polypropylene
Hernia System Product Underlay Onlay Connector EA/
Description
Code Patch Size Patch Size Size BX
Thick
471608 0.4mm - 0.8mm 6cm x 8cm
(0.8mm-1.7mm)
471812 0.8mm -1.7mm 8cm x 12cm
ETHICON SECURESTRAP®
Absorbable Strap Fixation Product
Device Description EA/BX
Code
Ligation
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EL214 Medium 1
EL314 Medium/Large 1
EL414 Large 1
Ligation
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Ligation
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LIGACLIP® Multi-Patient
Single-Clip Applier - Yellow Product Handle Clip EA/
Length Specification
Code Color Size BX
Surgical Stapling
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PCEE60A 280mm 12 3
PSEE60A 340mm 12 3
PLEE60A 440mm 12 3
PCE45A 280mm 12 3
PSE45A 340mm 12 3
PLE45A 440mm 12 3
PVE35A 320mm 12 3
Surgical Stapling
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Surgical Stapling
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Surgical Stapling
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1.0-
CDH21A 18cm 21mm 12.4mm 5.5mm 3
2.5mm
1.0-
CDH25A 18cm 25mm 16.4mm 5.5mm 3
2.5mm
1.0-
CDH29A 18cm 29mm 20.4mm 5.5mm 3
2.5mm
1.0-
CDH33A 18cm 33mm 24.4mm 5.5mm 3
2.5mm
1.0-
ECS21A 28cm 21mm 12.4mm 5.5mm 3
2.5mm
1.0-
ECS25A 28cm 25mm 16.4mm 5.5mm 3
2.5mm
1.0-
ECS29A 28cm 29mm 20.4mm 5.5mm 3
2.5mm
1.0-
ECS33A 28cm 33mm 24.4mm 5.5mm 3
2.5mm
Surgical Stapling
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ETHICON ENDO-SURGERY™
Linear Cutter Product Shaft Reload Maximum EA/
Articulation
Code Length Included Firings BX
1.5mm,1.8mm,
NTLC55 55mm 6 12 3
2.0mm
1.5mm, 1.8mm,
NTLC75 75mm 6 12 3
2.0mm
ETHICON ENDO-SURGERY™
Linear Cutter Cartridge Product Number of Selectable Closed EA/
Code Stapled Rows Staple Height BX
1.5mm,1.8mm,
SR55 6 12
2.0mm
1.5mm,1.8mm,
SR75 6 12
2.0mm
Surgical Stapling
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Surgical Stapling
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TR30 3
TL6R 3
TR90 3
TVR30 12
TRH30 12
TRH60 12
TRH90 12
Surgical Stapling
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PROXIMATE® Reloadable
Number Open Closed
Staplers (TX) Product Cartridge Tissue Reload Maximum EA/
of Staple Staple Staple
Code Color Thickness Included Firings BX
Rows Height Height
TX30V White 3 Vascular 2.5mm 1.0mm Yes 8 3
GYNECARE INTERCEED®
Absorbable Adhesion Barrier Product
Description EA/BX
Code
GYNECARE VERSAPOINT™
Bipolar Electrosurgery System Product
Description EA/BX
Code
GYNECAREGYNEMESH® PS
Nonabsorbable PROLENE® Product
Soft Mesh Size EA/BX
Code
Wound Closure
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OS-8 40mm
1/2 Circle
Tapercut
V-26 26mm
3/8 Circle 4-0 Violet 24cm X 24cm 1 SXPD2B424
2017 Ethicon Product Catalog | 67
Access Adjunctive Energy Hernia Repair Ligation Surgical Uterine & Wound Vascular Access Other
Hemostats & Fixation Stapling Pelvic Surgery Closure
Closure & Infection Control Devices
Wound Closure
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CT-1 36mm
1/2 Circle 0 Violet 30cm X 30cm 1 SXPD2B403
MO-4 36mm
1/2 Circle
CTX 48mm
1/2 Circle
Wound Closure
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Taperpoint
RB-1 17mm
1/2 Circle 3-0 Undyed 16cm X 16cm 1 SXMD2B402
Wound Closure
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CT-1 36mm
1/2 Circle
PS-1 24mm
3/8 Circle 3-0 Undyed 60cm 1 SXMD1B101
Taperpoint
Wound Closure
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SH 26mm
1/2 Circle 2-0 Undyed 20cm 1 SXMD1B406
PS-2 19mm
3/8 Circle 3-0 Violet 45cm 1 SXPD1B100
Taperpoint
CT-1 36mm
1/2 Circle 2-0 Violet 30cm 1 SXPD1B401
STRATAFIX™ Spiral
Polypropylene Knotless Taperpoint
Tissue Control Device
Unidirectional undyed
NEEDLE SUTURE USP COLOR LENGTH EACHES CODE
Wound Closure
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Product Adhesive
Description EA/BX
Code Volume
Product Adhesive
Description EA/BX
Code Volume
Product
Description EA/BX
Code
Wound Closure
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Product
Description EA/BX
Code
Product
Description EA/BX
Code
Product
Description EA/BX
Code
Product
Description EA/BX
Code
Wound Closure
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Suture Assistant
Product
Needle Type EA/BX
Code
SW100 N/A 4
Staple Extractor
Product Number
EA/BX
Code of Staples
Peripheral IVs,
Huber Needles
3/4" disc (1.9cm) (ports), Arterial
4151 <6Fr
w/1.Smm center hole Lines, Extended
Dwell PIVs, Midlines/
PICCS, Pins
Dialysis, Drians,
1" disc (1.9cm)
4152 13-20Fr Sheaths, Cordis,
w/2.5mm center hole
VAD drive Lines
Other Devices
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ENDOPATH® Scissors
Product
Description EA/BX
Code
ENDOPATH® Graspers
Product
Description EA/BX
Code
Other Devices
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ENDOPATH® Babcocks
Product
Description EA/BX
Code
ENDOPOUCH® Specimen
Retrieval Bag Product
EA/BX
Code
POUCH 6
ENDOPATH® Electrosurgery
PROBE PLUS® II System Product Common
Grip Control
Code Uses
Other Devices
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ENDOPATH® Electrosurgery
PROBE PLUS® II Electrode Shafts Product Shaft Shaft
Electrode EA/BX
Code Diameter Length
ENDOPATH® Electrosurgery
PROBE PLUS® II Tubing Product
Description EA/BX
Code
ETHICON ENDO-SURGERY®
Gastric Band Dissector Product
Description EA/BX
Code
ETHICON ENDO-SURGERY®
Gastric Calibration Tube Product
Description EA/BX
Code
Other Devices
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Other Devices
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Bariatric Surgery
Ethicon is committed to shaping the future of surgery in the fight against obesity and metabolic diseases
and helping to elevate the standard of care through research and evidence, best-in-class education and
training, innovating products and expanding patient access to care. Together, we’re advancing surgical
care, enabling patients to live longer, more fulfilling lives. For more information, click here.
Ethicon offers a comprehensive portfolio of market-leading, innovative devices to meet the changing
demands of today’s most effective surgical treatments for severe obesity, including:
Colorectal Surgery
Our commitment to colorectal surgery focuses on reducing risk factors that drive variability in outcomes
and costs. By combining innovation with education and research, we enable more predictability in
outcomes. For more information, click here.
Ethicon is addressing the most pressing challenges of today’s colorectal procedures through innovations
such as:
Bariatric Surgery Colorectal Surgery Gynecologic Surgery Hernia Repair Hepato-Billary Surgery Thoracic Surgery
Gynecologic Surgery
Our goal is to collaborate with the gynecologic community to help promote positive clinical outcomes. We
offer solutions to support a number of gynecological surgical procedures – both open and laparoscopic –
as well as a variety of techniques. For more information, click here.
Ethicon provides a broad portfolio of devices and products to help meet your clinical and economic
goals, including:
Hernia Repair
Ethicon’s commitment to advancing hernia repair is reflected in our ongoing investments in evidence,
innovative products, and best-in-class professional education. For more information, click here.
Ethicon provides essential solutions inspired by surgeon and patient needs, including:
Bariatric Surgery Colorectal Surgery Gynecologic Surgery Hernia Repair Hepato-Billary Surgery Thoracic Surgery
Hepato-Biliary Surgery
We are committed to developing flexible solutions for every aspect of cancer procedures – from supporting
education to funding research to delivering innovations that reduce the incidence and cost of managing
bleeding and infection-related complications. For more information, click here.
Ethicon offers a broad portfolio that delivers surgical precision and optimal hemostasis at every critical step
of complex HPB procedures. Out portfolio includes such key innovations as:
Thoracic Surgery
We are dedicated to procedural precision and have a renewed focus on bringing greater precision to every
aspect of thoracic surgery. Through training, research, and innovative products, we provide tools to enable
better outcomes in thoracic surgery. For more information, click here.
Our portfolio of innovative products is designed to address the most pressing challenges of today’s thoracic
procedures through innovation, including:
ECHELON FLEX™ Powered ECHELON FLEX™ GST System HARMONIC™ HD 1000i Shears
Vascular Stapler
Bariatric Surgery Colorectal Surgery Gynecologic Surgery Hernia Repair Hepato-Billary Surgery Thoracic Surgery
INDICATIONS
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary,
venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL®
ORIGINAL, SURGICEL® FIBRILLAR™ and SURGICEL® NU-KNIT® Hemostats can be cut to size for use in endoscopic procedures.
PRECAUTIONS
Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any
excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction.
In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent
plugging of the urethra, ureter, or a catheter by dislodged portions of the product.
Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by
application of silver nitrate or any other escharotic chemicals.
If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the
skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has
stopped.
Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples:
controlling hemorrhage after tonsillectomy and controlling epistaxis.)
Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse
Reactions).
ADVERSE REACTIONS
“Encapsulation” of fluid and foreign body reactions have been reported.
There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.
Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in
bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.
Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was
placed in the anterior cranial fossa.
Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.
INDICATION
INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostasis
when control of bleeding by ligature or conventional procedures is ineffective or impractical.
PRECAUTIONS
As with other hemostatic agents, it is not recommended that INSTAT MCH be left in an infected or contaminated space.
Safety of this product has not been established in pregnant women; therefore, it should only be used when benefit to risk clearly warrants its
use.
Another microfibrillar collagen agent has been reported to cause interference with the healing of skin edges when used in the closure of skin
incisions, and to reduce the strength of methyl methacrylate adhesives used to attach prosthetic devices to bone surfaces.
The long term effects of leaving INSTAT MCH in situ are unknown.
ADVERSE EVENTS
Adverse reactions reported with another microfibrillar collagen hemostatic agent that were possibly related to its use were adhesion formation,
allergic reaction, foreign body reaction, and subgaleal seroma (report of a single case). The use of microfibrillar collagen in dental extraction
sockets has been reported to increase the incidence of alveolalgia.
DESCRIPTION
SURGIFLO® Hemostatic Matrix Kit is intended for hemostatic use by applying to a bleeding surface.
ACTIONS
When used in appropriate amounts SURGIFLO® Hemostatic Matrix is absorbed completely within 4 to 6 weeks.
INTENDED USE/INDICATIONS
SURGIFLO® Hemostatic Matrix , mixed with with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic)
as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
CONTRAINDICATIONS
Do not use SURGIFLO® Hemostatic Matrix in intravascular compartments because of the risk of embolization.
Do not use SURGIFLO® Hemostatic Matrix in patients with known allergies to porcine gelatin..
Do not use SURGIFLO® Hemostatic Matrix in closure of skin incisions because it may interfere with the healing of skin edges. This interference
is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
WARNINGS
SURGIFLO® Hemostatic Matrix should not be used in the presence of infection and should be used with caution in contaminated areas of the
body.
SURGIFLO® Hemostatic Matrix should not be used in instances of pumping arterial hemorrhage. SURGIFLO® Hemostatic Matrix will not act as
a tampon or plug in a bleeding site.
SURGIFLO® Hemostatic Matrix should be removed from the site of application when used in, around, or in proximity to foramina in bone,
areas of bony confine, the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.
Excess SURGIFLO® Hemostatic Matrix should be removed once hemostasis has been achieved.
The safety and effectiveness of SURGIFLO® Hemostatic Matrix for use in ophthalmic procedures has not been established.
SURGIFLO® Hemostatic Matrix should not be used for controlling post-partum intrauterine bleeding or menorrhagia.
The safety and effectiveness of SURGIFLO® Hemostatic Matrix has not been established in children and pregnant women.
The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.
The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.
PRECAUTIONS
Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in
Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.
SURGIFLO® Hemostatic Matrix should not be used for packing unless excess product that is not needed to maintain hemostasis is removed.
SURGIFLO® Hemostatic Matrix may swell up to 20% upon contact with additional fluid.
SURGIFLO® Hemostatic Matrix should not be used in conjunction with autologous blood salvage circuits.
SURGIFLO® Hemostatic Matrix should not be used in conjunction with methylmethacrylate adhesives.
In urological procedures, SURGIFLO® Hemostatic Matrix should not be left in the renal pelvis or ureters to eliminate the potential foci for
calculus formation.
ADVERSE EVENTS
A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin
sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial
growth.
Giant cell granulomas have been observed at implant sites when used in the brain.
Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.
Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including
cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and
impotence.
The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy
operations, has been associated with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina
syndrome, neurogenic bladder, impotence, and paresis.
The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone
around the spinal cord, and blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal
skull fracture and lacerated lobe.
Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.
Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed
tendon repair.
Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.
Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.
DESCRIPTION
SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.
ACTIONS
When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.
INTENDED USE/INDICATIONS
SURGIFLO®, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when
control of bleeding by ligature or other conventional methods is ineffective or impractical.
CONTRAINDICATIONS
Do not use SURGIFLO® in intravascular compartments because of the risk of embolization.
Do not use SURGIFLO® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to
mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
WARNINGS
SURGIFLO® should not be used in the presence of infection and should be used with caution in contaminated areas of the body.
SURGIFLO® should not be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act as a tampon or plug in a bleeding site.
SURGIFLO® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine,
the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.
The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures has not been established.
SURGIFLO® should not be used for controlling post-partum intrauterine bleeding or menorrhagia.
The safety and effectiveness of SURGIFLO® has not been established in children and pregnant women.
The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.
The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.
PRECAUTIONS
Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in
Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.
SURGIFLO® should not be used for packing unless excess product that is not needed to maintain hemostasis is removed.
SURGIFLO® should not be used in conjunction with autologous blood salvage circuits.
In urological procedures, SURGIFLO® should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
ADVERSE EVENTS
A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin
sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial
growth.
Giant cell granulomas have been observed at implant sites when used in the brain.
Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.
Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including
cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and
impotence.
The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy
operations, has been associated with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina
syndrome, neurogenic bladder, impotence, and paresis.
The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone
around the spinal cord, and blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal
skull fracture and lacerated lobe.
Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.
Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed
tendon repair.
Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.
Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.
Do not apply intravascularly. This can result in life threatening thromboembolic events.
Do not use to treat bleeding from large defects in arteries or veins where the injured vascular wall requires conventional surgical repair and
maintenance of vessel patency or where there would be persistent exposure of EVARREST® to blood flow and/or pressure during absorption of
the product. Thrombosis can occur if absorbed systemically.
Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. EVARREST® can cause
hypersensitivity reactions including anaphylaxis.
Avoid application to contaminated areas of the body or in the presence of active infection. Infection can occur.
EVARREST® contains oxidized regenerated cellulose which adheres to bleeding surfaces. Inadvertent adhesions can occur.
Avoid use in, around, or in proximity to, foramina in bone or areas of bony confines where swelling may cause compression.
Use the least number of patches required to cover the entire bleeding area. Portions of excess patch material can become dislodged and
migrate to other areas of the body.
Do not use more than eight 2x4 inch (5.1 x 10.2 cm) or more than four 4x4 inch (10.2 x 10.2 cm) patches.
Use in patients who have been previously exposed to EVARREST® has not been studied.
May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent.
The adverse reactions reported during clinical trials occurred in less than 1% of all cases and included deep venous thrombosis, pulmonary
embolism, blood fibrinogen increase, anastomotic hemorrhage, post procedural and intra-abdominal hemorrhage, abdominal distension,
anemia, gastrointestinal hemorrhage, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, localized intra-abdominal fluid
collection, cardiac failure, operative hemorrhage, and ischemic bowel.
Pediatrics: Use in children under the age of one month may be unsafe or ineffective due to small size and limited ability to apply the patch as
recommended.
INDICATIONS
EVICEL ® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding
by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.
CONTRAINDICATIONS
Do not inject directly into the circulatory system. lntravascular application of EVICEL ® may result in life-threatening thromboembolic events.
Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
Do not use for the treatment of severe or brisk arterial bleeding.
Do not use EVICEL ® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip
to the target site cannot be ensured.
ADVERSE REACTIONS
The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may
occur in the presence of GYNECARE INTERCEED®.
INDICATIONS
GYNECARE INTERCEED® Absorbable Adhesion Barrier is indicated as an adjuvant in open Claparotomy) gynecologic pelvic surgery for reducing
the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.
CONTRAINDICATIONS
The use of GYNECARE INTERCEED® is contraindicated in the presence of frank infection. GYNECARE INTERCEED® is not indicated as a hemostatic
agent. Appropriate means of achieving hemostasis must be employed.
WARNINGS
The safety and effectiveness of GYNECARE INTERCEED® Adhesion Barrier in laparoscopic surgery or any procedures other than open
(laparotomy) gynecologic microsurgical procedures have not been established.
Postoperative adhesions may be induced by GYNECARE INTERCEED® application if adjacent tissues (eg, ovary and tube) and structures are
coapted or conjoined by the device, or if GYNECARE INTERCEED® is folded, wadded or layered. Postoperative adhesions may occur in the
presence of GYNECARE INTERCEED® if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE
INTERCEED® should not be placed in a contaminated surgical site.
PRECAUTIONS
Use only a single layer of GYNECARE INTERCEED®, since multiple layers of packing or folding will not enhance the adhesion barrier
characteristics and may interfere with the absorption rate of GYNECARE INTERCEED®. Care should be exercised in applying GYNECARE
INTERCEED® to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood prior to completing the procedure, it
should be discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesions formation. Ectopic pregnancies have
been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if any, of GYNECARE INTERCEED®
on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within the first
month after exposure to GYNECARE INTERCEED®. No teratogenic studies have been performed. Therefore, avoidance of conception should be
considered during the first complete menstrual cycle after use of GYNECARE INTERCEED®. The safety and effectiveness of using GYNECARE
INTERCEED® in combination with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED® is
supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED® must not be
resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNECARE INTERCEED® and some drugs
used at the surgical site. Pathologists examining sites of GYNECARE INTERCEED® placement should be made aware of its usage and of the
normal cellular response to GYNECARE INTERCEED® 'to facilitate proper evaluation of specimens'.
ADVERSE REACTIONS
The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may
occur in the presence of GYNECARE INTERCEED®.
© 2018 Ethicon
2017US,
Ethicon
LLC. Product
035213-180509
Catalog | 95