Identity
- Trade Name
- SmartTwist MR Hand Drill EUDAMEDSmartTwist FDA UDI
- Generic Name
- Manual cranial rotary handpiece, single-use FDA UDI
- Device Name
- SmartTwist MR Hand Drill EUDAMEDFDA UDI
- Model / Reference
- NGS-HD-01 EUDAMEDFDA UDI
- Description
- SmartTwist MR Hand Drill FDA UDI
Identifiers
- Catalog Number
- NGS-HD-01 FDA UDI
- Primary DI / UDI-DI
- 00850359007348 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850359007348C EUDAMED
- 510(k) Number
- K160129 FDA UDI
- FDA Product Code
- HBG FDA UDI
- EMDN Code
- Z12100902 DRILLS FOR NEUROSURGERY EUDAMED
- GMDN Term
- Manual cranial rotary handpiece, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4300 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
MR Conditional FDA UDI
SmartTwist MR Hand Drill by Clearpoint Neuro, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850359007348C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClearPoint Neuro, Inc.
- EUDAMED SRN
- US-MF-000010239
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED fefae8be-83c0-4f47-84df-bd29be1e0a5b 61 fields · synced Jul 18, 2026
- FDA UDI 84bc58ca-cc45-44c5-978b-9bf16aed2ab5 36 fields · synced May 30, 2026