FDA Device Establishments · JSON-LD · Markdown
FEI 3011578544 · Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3011578544 |
|---|---|
| Owner / Operator | Gentuity, LLC (#10073861) |
| Address | 142 North Road, Suite G, Sudbury, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | DQO, NQQ |
| Regulation § (21 CFR) | 870.1200, 892.1560 |
| Proprietary names | HF-OCT Imaging System with StentX Software |
Source: openFDA. Public-domain (CC0).