Identity
- Trade Name
- QFlow 500 5.3mm Drill Bit Kit FDA UDI
- Generic Name
- Intracerebral catheterization drill bit FDA UDI
- Device Name
- 5.3mm Drill Bit Kit FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- 5.3mm Drill Bit Kit FDA UDI
Identifiers
- Catalog Number
- H0000-3612 FDA UDI
- Primary DI / UDI-DI
- B238H000036120 FDA UDI
- 510(k) Number
- K141869 FDA UDI
- FDA Product Code
- HBG FDA UDI
- GMDN Term
- Intracerebral catheterization drill bit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Intracerebral catheterization drill bit
QFlow 500 5.3mm Drill Bit Kit by Hemedex, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracerebral catheterization drill bit.
- DRILL KIT CH9 — RAUMEDIC AG · Class II
- DRILL KIT CH5 — RAUMEDIC AG · Class II
- QFlow 500 2.7mm Drill Bit Kit — HEMEDEX, INC · Class II
Cleared under the same submission
K141869 also covers:
- QFlow 500 2.7mm Drill Bit Kit — HEMEDEX, INC
- QFlow 500 Bolt Accessory Kit — HEMEDEX, INC
- QFlow 500 Male-Female Luer Coupler — HEMEDEX, INC
- QFlow 500 Probe Dura Piercer and Introducer Kit — HEMEDEX, INC
- QFlow 500 Quad Lumen Cranial Bolt Large-Lumen Introducer — HEMEDEX, INC
- QFlow 500 Titanium Bolt-Dual Lumen — HEMEDEX, INC
- QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit — HEMEDEX, INC
- QFlow 500 Titanium Bolt-Dual Lumen Bolt Kit with Introducer — HEMEDEX, INC
- QFlow 500 Titanium Bolt-Quad Lumen Bolt Kit — HEMEDEX, INC
- QFlow 500 Titanium Bolt-Single Lumen — HEMEDEX, INC
- QFlow 500 Titanium Bolt-Single Lumen Bolt Kit — HEMEDEX, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemedex, Inc
Sources (1)
- FDA UDI de3a1af5-9098-4354-ade3-95e609e00140 35 fields · synced May 30, 2026