FDA Device Establishments · JSON-LD · Markdown
FEI 3018490308 · Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3018490308 |
|---|---|
| Owner / Operator | Kite Endoscopic Innovations LLC (#10081117) |
| Address | 10443 Johnnycake Ridge Rd, Concord Township, OH, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MJI |
| Regulation § (21 CFR) | 864.3010 |
| Proprietary names | Clam Shell, AFFIX |
Source: openFDA. Public-domain (CC0).