Device Dossier
Suture, polytetrafluoroethylene
Device Dossier for Suture, polytetrafluoroethylene (Suture, polytetrafluoroethylene, Class IIa, sponsor Osstem). ARTG record, intended purpose, GMDN…
- GMDN category: Suture, polytetrafluoroethylene
Intended purpose
The Cytoplast PTFE Suture is a non-absorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene that has been expanded to produce a microporous structure (e-PTFE). The Cytoplast PTFE Suture meets all USP and EP requirements (diameter, knot-pull, and needle-pull). The suture is undyed and contains no additives. The Cytoplast PTFE Suture is supplied sterile with attached standard surgical needles in a variety of sizes.