FDA Device Establishments · JSON-LD · Markdown
FEI 3021630097 · Manufacture Medical Device · Status: Active
| FEI Number | 3021630097 |
|---|---|
| Owner / Operator | Gentuity, LLC (#10073861) |
| Address | 28 Crosby Drive, Bedford, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | NQQ, ORD |
| Regulation § (21 CFR) | 892.1560, 870.1200 |
| Proprietary names | Gentuity HF-OCT Imaging System; Vis-Rx® Micro-Imaging Catheter; Gentuity® HF-OCT Imaging System |
Source: openFDA. Public-domain (CC0).