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Non-absorbable Polypropylene Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days. Non-absorbable Polyester Suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days. Non-absorbable Polyamide suture is indicated for use in general soft tissue approximation and/or ligation. The device can be left in place for a maximum of 30 days.

The applicant devices of Non-absorbable Polypropylene Suture consist of polypropylene surgical suture made of polypropylene and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by §74.3045 [Phthalocyaninato(2-)] copper.(CI Number 74160) which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polypropylene Suture are available in 11-0, 10-0, 8 -0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia. The applicant devices of Non-absorbable Polyester Suture consist of a polyester surgical suture made of polyester and a stainless steel needle. It is braided and coated with silicone. It is EO sterilized, and prygon-free.It is undyed (natural white) or dyed green with § 74.3206 D&C Green No. 6. (CI Number 61565), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyester Suture are available in 9-0, 8-0, -0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia. The applicant devices of Non-absorbable Polyamide suture consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is monofilament. It is EO sterilized, and prygon-free. It is dyed by § 74.3102 FD&C Blue No. 2. ( CI Number 73015) or § 73.1410 Logwood Black (CI Number 75290), which is less than 0.1 % by weight. The applicant devices of Non-absorbable Polyamide suture are available in 11-0, 10-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 1, 2 and 3, which are the sizes identified in the currently recognized United States Pharmacopoeia. The proposed devices are provided sterile and single use. The proposed device is composed of suture with or without the needle. The needle is made of stainless steel. The needles are available in six types: Taper, Cutting, Taper Cutting, Reverse Cutting, Diamond, Premium Cutting and Spatula. The Arc (Circle) of needle has 1/4 circle, 3/8circle,1/2circle,5/8circle,compound curve, straight. The proposed devices are provided in various combinations of suture length, diameter, color (dyed or undyed), quantity of needle and needle types. The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.