SURGEASY BRAIDED POLYESTER
(Ethylene Terephthalate) suture
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COATED, NONABSORBABLE SURGICAL SUTURES
DESCRIPTION:
BRAIDED POLYESTER is nonabsorbable sterile, surgical suture composed of Poly (Ethylene Terephthalate). It is prepared from fibers of high-molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component. The braided sutures are available uncoated or coated uniformly with silicone to increase surface lubricity, to enhance handling, ease passage through tissue and knot run-down properties. BRAIDED POLYESTER sutures are dyed with D&C green #6 and are also available undyed (white).
BRAIDED POLYESTER meets all requirements established by the United States Pharmacopeia (USP) for Nonabsorbable Surgical Suture.
INDICATIONS:
BRAIDED POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
ACTIONS:
BRAIDED POLYESTER elicits a minimal acute inflammatory reaction in tissues, followed by gradual encapsulation of the suture by fibrous connective tissue. BRAIDED POLYESTER is not absorbed, nor is any significant change in tensile retention known to occur in-vivo.
CONTRAINDICATIONS:
None Known.
WARNINGS:
Do not resterilize. Discard open, unused sutures.
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 calcuius formation.
Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing BRAIDED POLYESTER for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.
Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated 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 technique 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, 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 transitory local irritation.
HOW SUPPLIED:
BRAIDED POLYESTER sutures are available as sterile, undyed (white) or dyed with D&C green #6 and braided mated uniformly or uncoated, in U.S.P. sizes 6-0 through 2 (metric sizes 0.7 - 5.0), in a variety of lengths, with and without permanently attached needles. BRAIDED POLYESTER sutures are available in one and three dozen boxes.
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