Identity
- Trade Name
- neuro|mate® - Temporary implant insert FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- A part of the fiducial fixation kit, indispensable for the ultrasound Frameless mode. It is screwed on the patient's skull during a surgical action. FDA UDI
- Model / Reference
- Fiducial fixation kit FDA UDI
- Description
- A part of the fiducial fixation kit, indispensable for the ultrasound Frameless mode. It is screwed on the patient's skull during a surgical action. FDA UDI
Identifiers
- Catalog Number
- 003.0064 FDA UDI
- Primary DI / UDI-DI
- 03662724000147 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
No
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
Moist Heat or Steam Sterilization FDA UDI
neuro|mate® - Temporary implant insert by Renishaw Mayfield — 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
- Renishaw Mayfield
Sources (1)
- FDA UDI d8cd8b1c-cff8-48cc-a841-1fceb67e9b11 36 fields · synced May 30, 2026