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Description

Polyamide suture is nonabsorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6 Nylon 6,6. The suture is provided dyed (black or blue), or undyed (clear). The pigment for the black dyed suture is Hematein (Logwood) black, the pigment for the blue dyed is FD&C #2 blue. The suture is packaged both dry or in a wetting solution of 90% Isopropyl Alcohol, 0.5% Diethylethanolamine, 0.5% Sodium Benzoate (U.S.P Grade) and Water Q.S. AD 100%. The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.

Indications

Polyamide Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Actions

Polyamide Suture elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. While Polyamide is not absorbed, progressive hydrolysis of the nylon in vivo may result in gradual loss of its tensile strength over time.

Contraindications

Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, Polyamide Suture should not to be used where permanent retention of tensile strength is required.

Warnings

DO NOT RESTERILIZE. DISCARD OPEN UNUSED SUTURES. STORE AT COOL ROOM TEMPERATURE. AVOID PROLONGED EXPOSURE TO ELEVATED TEMPERATURES.

As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing Polyamide suture for wound closure as risk of wound dehiscence may vary with the site of application and the suture material used. Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds.

Precautions

In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments, such as forceps or needle holders. Adequate knot security requires the accepted surgical techniques of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments.

Adverse Reactions

Adverse effects associated with the use of this device include: wound dehiscence, gradual loss of tensile strength over time, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions, such as urine and bile occurs, infected wounds, minimal acute inflammatory tissue reaction, and pain, edema and erythema at the wound site.

How Supplied

Polyamide surgical suture is available in braided U.S.P. sizes 8-0 through 5 (metric 0.4 through 6), and in monofilament sizes 11-0 through 4 (metric sizes 0.1 through 6). The suture is supplied sterile in pre-cut lengths, both nonneedled and affixed to various needle types in one dozen boxes.

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