OVIS COG

Primary DI

08800056900017

Basic UDI-DI Code

B-08800056900017

Reference

L-LL19G38(2)

Device Types

Single use

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Ovistech Co., Ltd.

Polydioxanone is used for biomedical applications, particularly in the preparation of surgical sutures. Other biomedical applications include orthopedics, plastic surgery, drug delivery, cardiovascular applications, and tissue engineering. It is degraded by hydrolysis, and the end products are mainly excreted in urine, the remainder being eliminated by digestive or exhaled as CO2. The biomaterial is completely reabsorbed in 6 months and can be seen only a minimal foreign body reaction tissue in the vicinity of the implant. Materials made of PDO can be sterilized with ethylene oxide

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).