Device Dossier
Suture, polypropylene monofilament
Device Dossier for Suture, polypropylene monofilament (Polyolefin/fluoropolymer suture, monofilament, Class IIa, sponsor Biogen Medi). ARTG record,…
- GMDN category: Polyolefin/fluoropolymer suture, monofilament
Intended purpose
Biotex is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body should be less than 30 days.