Identity
- Trade Name
- SmartFrame XG Targeting Cannula EUDAMEDClearPoint FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- SmartFrame XG Targeting Cannula EUDAMEDFDA UDI
- Model / Reference
- NGS-TC-01 EUDAMEDFDA UDI
- Description
- SMARTFrame XG Targeting Cannula FDA UDI
Identifiers
- Catalog Number
- NGS-TC-01 FDA UDI
- Primary DI / UDI-DI
- 00850376007840 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850376007848N EUDAMED
- 510(k) Number
- K200079 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12100685 STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Italy 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 Safe FDA UDI
SmartFrame XG Targeting Cannula 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 | 0850376007848N | 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 beeb65e4-926b-46e5-9c16-f3f76b3ffebd 61 fields · synced Jul 9, 2026
- FDA UDI 9aecf1f3-1873-4f10-81e8-6268e4234069 36 fields · synced May 30, 2026