FDA Device Establishments · JSON-LD · Markdown

OSSAWARE BIOTECH CO., LTD.

FEI 3013340866 · Manufacture Medical Device · Status: Active

FEI Number3013340866
Owner / OperatorOSSAWARE BIOTECH CO., LTD. (#10075919)
AddressNo. 51, Xinggong Rd.,, Shenkang Hsiang Changhua, 50971, TW
Mandatory US AgentCusmed Biotech LLC
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)GXR
Regulation § (21 CFR)882.5250
Proprietary names99050139S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 13mm/9mm, Sterile; 9901001.15S connectCMF Flap Fixator, Anti-loose Type+Screwdriver, PEEK, D15mm, Sterile; 9900102.20S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D20mm, Sterile; 9905014.11S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile; 9906014.11S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver for Shunt & ICP, PEEK, 14mm/11mm, Sterile; 9900001.15S connectCMF Flap Fixator, Replaceable Type+Screwdriver, PEEK, D15mm, Sterile; 9904104.22S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D22mm, Sterile; 99050118S CirFIX Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 11mm/8mm, Sterile; 9903101.15S connectCMF Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile; 9904002.20S connectCMF Flap Fixator, Low Profile Anti-loose Type+Screwdriver, PEEK, D20mm, Sterile

External sources

Source: openFDA. Public-domain (CC0).