Device Dossier
TESSLIFT SOFT (vderm) - Suture, polydioxanone
Device Dossier for TESSLIFT SOFT (vderm) - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor Ebos Medical Devices). ARTG record, intended…
- GMDN category: Suture, polydioxanone
- Sponsor: Ebos Medical Devices
Intended purpose
This sterile device is made of absorbable polydioxanone suture. The device is used to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The implanted suture is degraded by hydrolysis after the procedure and takes about 180-220 days to be fully absorbed in the body.
Functional description
TESSLIFT SOFT(vderm) models are composed of eight suture strands of the same wrapping material added to a barbed polydioxanone central suture that is inserted through a cannula into skin or tissue to fixate subdermal tissue in an elevated position. The suture remains in the implantation site while the needle is removed. The suture is dyed purple. The moisture content of the suture is 500 ppm (0.05%) or less. Suture is absorbed completely after 6 months.