FDA Device Establishments · JSON-LD · Markdown
FEI 3002807111 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3002807111 |
|---|---|
| Owner / Operator | Sotera Health LLC (#10029425) |
| Address | Zoning Industriel de Petit-Rechain, Avenue Andre Ernst 21, Verviers Liege, B-4800, BE |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | NPU, NPT |
| Proprietary names | Edwards Certitude Delivery System; Edwards Commander Delivery System; Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards Certitude Introducer Sheath Set; Edwards Crimper; Edwards eSheath Introducer Set- 916ES; eSheath- 916ES; eSheath- 914ES; Edwards eSheath Introducer Set- 914ES; Edwards SAPIEN 3 Ultra Delivery System |
Source: openFDA. Public-domain (CC0).