ORTHOFLEX ONE

Primary DI

05944728007550

Basic UDI-DI Code

B-05944728007550

Reference

ORTHOFLEX ONE

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Rompharm Company SRL

ORTHOFLEX ONE is a sterile, viscoelastic solution containing two highly purified cross-linked biological polymers, sodium hyaluronate and chondroitin sodium sulfate. ORTHOFLEX ONE consists of sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain and chondroitin sodium sulfate produced from bovine cartilage. ORTHOFLEX ONE is a sterile viscoelastic solution processed using an aseptic processing technique and supplied in a disposable glass syringe delivering 3 mL of solution.

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