FDA Device Establishments · JSON-LD · Markdown
FEI 1000560772 · Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device · Status: Active
| FEI Number | 1000560772 |
|---|---|
| Owner / Operator | BioSculptor Corporation (#10028416) |
| Address | 2480 W 82nd St Unit 1, Hialeah, FL, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IQI |
| Regulation § (21 CFR) | 890.3475 |
| Proprietary names | Maramed Orthopedic Systems; Miami Fracture Brace; TFB, TFB-PS, UFB; CFB, EO, EO-SG, FC, FFB, HFB, HFB-OS, HFB-SG; Plastic Colles Splint, Plastic Femur Splint, Plastic Forearm Splint, Plastic Tibia Splint; Maramed; Plastic Tibia/Fibula Splint; Sky Medical Humeral Facture Orthosis Deltoid Extension, HFO-DE; Sky Medical Humeral Fracture Orthosis, HFO; Sky Medical Ulna Fracture Brace, UFO |
Source: openFDA. Public-domain (CC0).