Device Dossier

Suture, polyethylene

Device Dossier for Suture, polyethylene (Suture, polyethylene, Class IIb, sponsor Life Healthcare). ARTG record, intended purpose, GMDN category —…

Intended purpose

A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g polyethylene) intended to join (i.e, approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. tis not a barbed suture and does not include antimicrobial agents/ materials. This is a single-use device intended to be used in a sterile condition.

TGA Public Summary