Identity
- Trade Name
- SmartFrame FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- SMARTFrame Scalp Mount Kit w/ HC FDA UDI
- Model / Reference
- CP-NGS-11-HC-SCM FDA UDI
- Description
- SMARTFrame Scalp Mount Kit w/ HC FDA UDI
Identifiers
- Catalog Number
- CP-NGS-11-HC-SCM FDA UDI
- Primary DI / UDI-DI
- 00850359007034 FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- 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
SmartFrame by Clearpoint Neuro, Inc. — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Clearpoint Neuro, Inc.
Sources (1)
- FDA UDI 36a9398f-ee9e-4f3f-ae37-8b33c481db55 37 fields · synced Jun 8, 2026