Identity
- Trade Name
- SmartTip FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- SmartTip MRII Drill Kit, 3.2-mm FDA UDI
- Model / Reference
- NGS-DB-01 FDA UDI
- Description
- SmartTip MRII Drill Kit, 3.2-mm FDA UDI
Identifiers
- Catalog Number
- NGS-DB-01 FDA UDI
- Primary DI / UDI-DI
- 00850359007355 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
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
Yes
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
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.2 Millimeter FDA UDI
SmartTip by Clearpoint Neuro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Clearpoint Neuro, Inc.
Sources (1)
- FDA UDI 98a94a97-7af6-42cd-a5bb-a8fa4e459b2c 37 fields · synced May 30, 2026