Device Dossier

Monoglyc- Suture, polydioxanone

Device Dossier for Monoglyc- Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Biomedent). ARTG record, intended purpose, GMDN category —…

Intended purpose

This is a synthetic absorbable suture product copolymer polyglycolic acid and caprolactone (PGA-PCL)monofilament. Monoglyc is intended to be used for coaptation of soft tissues in the surgical disciplines of oral surgery, dermatology surgery, plastic surgery, obstetrics, gynecologic surgery, urological surgery and for gastrointestinal anastomoses.

Functional description

Monoglyc is a monofilament, synthetic sterile surgical suture material that is absorbable and consists of a copolymer of glycolic acid and Poly (glycolide-co-caprolactone). The characteristic feature of Monoglyc is the rapid loss of tear resistance.

TGA Public Summary