Identity
- Trade Name
- ClearPoint FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- ClearPoint Fiberoptic Monitor w-Mouse System FDA UDI
- Model / Reference
- CP-MON-02 FDA UDI
- Description
- ClearPoint Fiberoptic Monitor w-Mouse System FDA UDI
Identifiers
- Catalog Number
- CP-MON-02 FDA UDI
- Primary DI / UDI-DI
- 00850359007553 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
ClearPoint 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 d0fb2a12-58a7-40e3-ac6a-dea3f19fb6ed 37 fields · synced May 30, 2026