ORTHOFLEX GEL

Primary DI

05944728007048

Basic UDI-DI Code

B-05944728007048

Reference

ORTHOFLEX GEL

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Rompharm Company SRL

ORTHOFLEX GEL is a bio-matrix in the form of a sterile, viscoelastic solution consisting of two highly purified cross-linked biopolymers, sodium hyaluronate and chondroitin sodium sulfate, and N-acetylglucosamine (NAG), a naturally amino sugar. ORTHOFLEX GEL contains sodium hyaluronate derived from bacterial fermentation of a Streptococcus strain, chondroitin sodium sulfate sourced from bovine cartilage, and NAG sourced from chitin, a naturally long-chain polymer of N-acetylglucosamine. ORTHOFLEX GEL is a sterile viscoelastic solution processed by aseptic technique and supplied in a disposable glass syringe delivering 2.25 mL of solution.

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