FDA Device Establishments · JSON-LD · Markdown
FEI 3015332213 · Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device · Status: Active
| FEI Number | 3015332213 |
|---|---|
| Owner / Operator | Ostoform Ltd (#10060178) |
| Address | Ostoform Limited, Unit 5C Fairgreen House, St. Lomans Terrace, Mullingar Westmeath, N91 H635, IE |
| Mandatory US Agent | Ostoform Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EXE |
| Regulation § (21 CFR) | 876.5900 |
| Proprietary names | Ostoform FLOWASSIST Convex Baseplate; Ostoform Barrier Extender; Ostoform FLOWASSIST Flat Baseplate; Ostoform Crest Moldable Barrier; FLOWASSIST Seal |
Source: openFDA. Public-domain (CC0).