FDA Device Establishments · JSON-LD · Markdown
FEI 3003117688 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3003117688 |
|---|---|
| Owner / Operator | Sotera Health LLC (#10029425) |
| Address | Parque Industrial Tepeji, Calle North 7 s/n, Tepeji del Rio de Ocampos Hidalgo, CP 42850, MX |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | GDW, NAY |
| Regulation § (21 CFR) | 878.4750, 876.1500 |
| Proprietary names | Xi Conductive Reducer - 470381; Xi Reducer (12-8mm), (470381-04, 05, 06, 07, 08, 09); Xi Ports Seal (12mm & Stapler), (470380-04, 05, 06, 07); Xi Stapler 45 Reload (Green) - 48445G; Xi Stapler 45 Reload (White) - 48645W; Xi Seal (12mm & Stapler) - 470380; Xi Stapler 45 Reload (Blue) - 48645B; Si Stapler Sheath - 410370; 12 mm & Stapler Cannula Seal - 470380 |
Source: openFDA. Public-domain (CC0).