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This product consists of sterile, synthetic, absorbable monofilament sutures made from polydioxanone. The suture material is dyed violet for enhanced visibility during surgical procedures. It is designed for use in tissues that require extended wound support, gradually losing its tensile strength over a period of approximately six weeks.
The absorption process is completed through hydrolysis, with the material being fully absorbed by the body within 180 to 210 days. Each unit contains a 70 cm length of suture attached to a 30 mm, 1/2 circle, round body heavy needle. The needle is constructed from SS 420 stainless steel alloy and is silver in color.
This configuration is provided in a box containing 12 individual foil packages, each ensuring sterility until the point of use. The suture is classified under USP 0 size. The needle's round body heavy design is suitable for penetrating tougher tissues.
The material's inherent properties offer predictable strength retention, with approximately 70% of its original tensile strength remaining at two weeks post-implantation, 50% at four weeks, and 25% at six weeks. This gradual decrease in strength is a key characteristic for applications requiring prolonged tissue approximation. The synthetic nature of the polydioxanone polymer minimizes tissue reactivity compared to some natural absorbable materials.
The monofilament construction also contributes to a smooth passage through tissue, reducing drag and potential tissue trauma. The suture is sterilized using Ethylene Oxide (ETO) gas through a validated T.S.
Cycle process to ensure sterility. This product is intended for single use only and should be handled and disposed of according to standard medical waste protocols. It is important to select the appropriate suture size and needle type based on the specific surgical procedure and tissue characteristics.
The dyed violet color aids in distinguishing the suture from surrounding tissues, particularly in deep or bloody surgical fields, which can improve surgical accuracy and efficiency. The absorbable nature eliminates the need for suture removal in many applications, potentially reducing patient discomfort and the risk of complications associated with retained foreign material. The PDS II suture line is recognized for its reliability in various surgical disciplines where absorbable wound closure is indicated.
The 1/2 circle needle geometry is versatile and commonly used in general surgery, obstetrics, gynecology, and other specialties requiring precise needle manipulation. The heavy designation of the needle indicates a robust construction suitable for challenging tissue dissection and closure.
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