FDA Device Establishments · JSON-LD · Markdown
FEI 3008132411 · Sterilize Medical Device for Another Party (Contract Sterilizer) · Status: Active
| FEI Number | 3008132411 |
|---|---|
| Owner / Operator | Sotera Health LLC (#10029425) |
| Address | A603 Lane 108, No. 588, Chuantu Road, ChuanSha, Pudong, Shanghai, 201202, CN |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LMG |
| Regulation § (21 CFR) | 878.4490 |
| Proprietary names | PerClot® Polysaccharide Hemostatic System |
Source: openFDA. Public-domain (CC0).