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The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.

Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II. The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.

Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.

Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.

Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".

Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.

UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.

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MONOCRYL* Plus Antibacterial (poliglecaprone 25) sutures (dyed or undyed) are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

MONOCRYL* Plus Antibacterial (poliglecaprone 25) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and epsilon-caprolactone. The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broadspectrum antibacterial agent, at no more than 2360 ug/m.

The AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.

The AUTOBAHN Tissue Closure Device is a non-sterile, reusable device for use with the AUTOBAHN Disposable Cartridge. The AUTOBAHN Disposable Cartridge is a sterile; single-use disposable cartridge containing a standard type needle and standard, absorbable and non-absorbable, suture that is attached to the reusable AUTOBAHN Tissue Closure Device. The AUTOAHN Tissue Closure Device and Disposable Cartridge are indicated for soft tissue approximation and/ or ligation in general surgical procedures. The needle is contained within the AUTOBAHN Disposable Cartridge before, during, and after the case, aiding in the prevention of suture needle sticks to the surgeons, nurses, and OR staff. The AUTOBAHN tissue Closure Device needle is driven around inside the cartridge in a complete 360° arc. A completed stitch is placed each time the needle and suture are driven across the aperture and through tissue located within the aperture.

The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures. The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures. It is designed to aid in the prevention of suture needle stick injuries.

The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.

SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

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Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.