FDA Device Establishments · JSON-LD · Markdown
FEI 3006536454 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3006536454 |
|---|---|
| Owner / Operator | KYOCERA Medical Corporation (#9097359) |
| Address | 10-1 KAWAI-CHO, Higashiomi-shi Shiga, 529-1571, JP |
| Mandatory US Agent | Hastings Regulatory Consulting, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LZO |
| Regulation § (21 CFR) | 888.3353 |
| Proprietary names | DYNASTY CERAMIC FEMORAL HEAD 44 and 48mm Alumina Ceramic Femoral Heads; DYNASTY CERAMIC FEMORAL HEAD 28,32,36,38,40,42 and 46mm Alumina Ceramic Femoral Heads |
Source: openFDA. Public-domain (CC0).