Identity
- Trade Name
- SmartFrame Guide Tubes (Set) EUDAMEDSmartFrame FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- SmartFrame Guide Tubes (Set) EUDAMEDSMARTFrame Guide Tubes FDA UDI
- Model / Reference
- NGS-GT-01 EUDAMEDFDA UDI
- Description
- SMARTFrame Guide Tubes FDA UDI
Identifiers
- Catalog Number
- NGS-GT-01 FDA UDI
- Primary DI / UDI-DI
- 00850359007232 EUDAMEDFDA UDI
- Basic UDI-DI
- 08503590072387 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 Guide Tubes (Set) 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 | 08503590072387 | 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 4d4ced56-102a-4e6b-b8cb-fe11de4ed1ee 61 fields · synced Jul 9, 2026
- FDA UDI 1ff1e8df-453b-4044-9aa1-71c6ecc39948 36 fields · synced May 30, 2026