FDA Device Establishments · JSON-LD · Markdown
FEI 3003730855 · Manufacture Medical Device · Status: Active
| FEI Number | 3003730855 |
|---|---|
| Owner / Operator | HEMEDEX INCORPORATED (#9048090) |
| Address | 564 Main Street, Suite 300, North Waltham, MA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | HBG, GWM |
| Regulation § (21 CFR) | 882.4300, 882.1620 |
| Proprietary names | QFLOW 500TM TITANIUM BOLT Dual Lumen; QFLOW 500TM TITANIUM BOLT Single Lumen Bolt Kit with Dura Piercer; QFLOW 500TM 5.3 mm Cranial Drill Bit; QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit; QFLOW 500TM TITANIUM BOLT Quad Lumen Bolt Kit; QFLOW 500TM TITANIUM BOLT Single Lumen; QFLOW 500TM 2.7 mm Cranial Drill Bit; QFLOW 500TM Accessories, Touhy Borst / Compression Fitting 0-9 FR; QFLOW 500TM TITANIUM BOLT Dual Lumen Bolt Kit with Introducer; QFLOW 500TM Accessories, Bolt Accessories Kit |
Source: openFDA. Public-domain (CC0).