Identity
- Trade Name
- Drill Bit FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Drill Bit 1.7 mm, Single-Use FDA UDI
- Model / Reference
- 352-01-00 FDA UDI
- Description
- Drill Bit 1.7 mm, Single-Use FDA UDI
Identifiers
- Primary DI / UDI-DI
- G2843520100 FDA UDI
- 510(k) Number
- K192162 FDA UDI
- FDA Product Code
- HBG FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Drill Bit by Neurovention LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K192162 also covers:
- Drill Bit — Neurovention LLC
- KTC Burr Hole Cover — Neurovention LLC
- KTC Burr Hole Cover — Neurovention LLC
- NuCrani Large Plate — Neurovention LLC
- NuCrani Small Plate — Neurovention LLC
- Rescue Screw Torx Slot — Neurovention LLC
- Screw T6 Torx — Neurovention LLC
- Screw Torx Slot — Neurovention LLC
- Screw Torx Slot — Neurovention LLC
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
- Neurovention LLC
Sources (1)
- FDA UDI 80ae1200-038f-4c74-8709-b70b9f49d301 35 fields · synced Jun 8, 2026