FDA Device Establishments · JSON-LD · Markdown
FEI 3021230784 · Manufacture Medical Device · Status: Active
| FEI Number | 3021230784 |
|---|---|
| Owner / Operator | DISA Medinotec (Pty) Ltd (#10083849) |
| Address | Stand 171, Northlands Business Park, Bush Telegraph Street,, Northriding, Johannesburg Gauteng, 2169, ZA |
| Mandatory US Agent | Biologics Consulting |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OZT |
| Regulation § (21 CFR) | 870.1255 |
| Proprietary names | OutFlo Aortic Valve Valvuloplasty Perfusion Dilatation Catheter |
Source: openFDA. Public-domain (CC0).