FDA Device Establishments · JSON-LD · Markdown
FEI 3003182398 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3003182398 |
|---|---|
| Owner / Operator | MEDINOL LTD. (#9031416) |
| Address | 8 Hartom Street Beck Tech Bldg. Har Hotzvim B,, Jerusalem, 9777508, IL |
| Mandatory US Agent | CardioMed Device Consultants, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LOX |
| Regulation § (21 CFR) | 870.5100 |
| Proprietary names | NC Gallant PTCA Dilatation Catheter |
Source: openFDA. Public-domain (CC0).