Device Dossier

21 Century Sterile Single use Polydioxanone suture with needle - Suture, polydioxanone

Device Dossier for 21 Century Sterile Single use Polydioxanone suture with needle - Suture, polydioxanone (Suture, polydioxanone, Class III, sponsor RAAN…

Intended purpose

The absorbable polydioxanone suture with needle is intended for use for facial soft tissue reconstruction in the asymmetry.

Functional description

The sterile single use polydioxanone (PDO) suture with needle consists of a suture, sponge, cannula, hub, and a protect cap. When the PDO threads are inserted into the dermal layer of the skin, they are characterized by being absorbed in the patient's face.

TGA Public Summary