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The Tissue Approximation System (TAS) is indicated for use in soft tissue approximation, including use in general surgery procedures such as minimally invasive ventral hernia and abdominal wall closure less than 10cm, but not for use in ophthalmic, neurologic, or cardiovascular procedures.

The Tissue Approximation System (TAS) consists of a polyamide (nylon) "zip-tie" attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots. When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.

The Golnit Nylon Monofilament Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neurological procedures.

The Golnit Nylon Monofilament Suture is a synthetic monofilament nonabsorbable sterile surgical suture composed of the long-chain aliphatic polymers Nylon 6,6. The suture is pigmented black (logwood extract) or blue (FD&C Blue No. 2) to enhance visibility or is also available undyed (clear). The suture has been designed to meet the requirements of the United States Pharmacopeia (USP) related to diameter, needle attachment and tensile strength. The suture is supplied sterile and is provided according to customer specifications. The device is available in pre-cut lengths from 10 cm to 300 cm in 5 cm intervals and in USP sizes 10-0 through 2. It can be attached to a stainless-steel needle or be without a needle. Needles are available with various tip shapes (taper, cutting, reversecutting, taper-cutting, spatula, and diamond), curvatures (1/2, 3/8, 5/8, 1/4 or straight) and lengths (4 mm to 70 mm). Each suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The suture is sterilized by ethylene oxide and is intended for single use only.

Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days.

The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%.

CROWNJUN Nylon Suture is intended to join the edges of soft-tissue wound or incision to ligate soft tissues.

The CROWNJUN Nylon Suture is a sterile nonabsorbable polyamide surgical suture. The CROWNJUN Nylon Suture is composed of long-chain aliphatic polymers polyamide 6,6 which is available undyed or dyed black using logwood extract (Hematein) per 21 CFR 73.1410. The CROWNJUN Nylon Suture is offered in diameters ranging from USP size 12-0 through USP 0 and available in various lengths from 2.5 cm to 90 cm with pre-attached needles. The needle is composed of 300 series stainless steel of various types of tip shapes, curvatures, and sizes. The product meets all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures.

REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304. REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural). REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304. REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural). REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

Dafilon Nonabsorbable Polyamide Surgical Sutures are indicated for use in all types of general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, microsurgery and neurological procedures.

Dafilon is a nonabsorbable monofilament surgical suture which is supplied sterile. Dafilon is composed of the long-chain aliphatic polymers polyamide 6 and/or 6,6. The Dafilon suture is offered undyed and dyed with FDA approved colorants Logwood extract in accordance with Title 21 CRF, §73.1410 or [Phthalocyaninato(2-)] copper in accordance with Title 21 CFR, §74.3045. The Dafilon suture will be offered in diameters ranging from USP size 11-0 through 5 and will be available in a variety of cut lengths with out needles attached.

RiverLon Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

The Riverpoint Medical RiverLon Nylon Sutures are inert, non-absorbable, sterile surgical sutures composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6/6. RiverLon sutures are available in common sizes and length with or without pre-attached needles.

The nonabsorbable sutures (Monofilament Nylon, Polypropylene and Silk) are indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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The Kumar T-ANCHORS Hernia Set provides a means for fixation of prosthetic material and passage of sufure during repair of hernia and soft tissue.

Kumar T-Anchors Hernia Set supplies 8 T-Anchors that carry size 0 polyamide suture. These are deployed in pairs percutaneously through a 16 ga, needle. The sutures are tied to anchor the prosthetic material to the abdominal wall in repair of hernia or the soft tissues.

FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.

FSSB Nylon Surgical Suture is a monofilament non-absorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6,6. The suture is provided dyed (black). The pigment for the black dyed suture is Hematein black (Logwood: Color Code 75290). All products meet the requirements of 21 CFR 70.5(c) regarding the use of color additives in sutures. The product is available in several lengths and USP diameters. The FSSB Surgical Suture is equipped with single or double high-grade stainless steel needles of various types of points, lengths, diameters and curves (Product List provided as Appendix A). The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.