Device Dossier

CRYLREX Synthetic Multifilament Absorbable Suture Polyglactin 910 with/without needle - Suture, polyglactin

Device Dossier for CRYLREX Synthetic Multifilament Absorbable Suture Polyglactin 910 with/without needle - Suture, polyglactin (Suture, polyglactin,…

Intended purpose

A sterile thread made from polyglactin that is used to join the edges of a wound or incision by stitching. this product has or has not got a needle attached, it is use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue. this is a single use product

Functional description

The Device is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is avaliable for both dyed and undyed. When dyed, only FDA-approved color additives such as D&C violet No. 2 are used. The undyed suture is milk white (beige) in color. Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70days.

TGA Public Summary