Identity
- Trade Name
- neuro|mate® - Frameless Head-holder kit FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- The head-holder kit consists of a half-ring, six pins, a clip for fixing the half-ring onto the head-holder attachment. The kit is fixed on the base of the neuro|mate®. FDA UDI
- Model / Reference
- Frameless Head-holder kit FDA UDI
- Description
- The head-holder kit consists of a half-ring, six pins, a clip for fixing the half-ring onto the head-holder attachment. The kit is fixed on the base of the neuro|mate®. FDA UDI
Identifiers
- Catalog Number
- 001.0030 FDA UDI
- Primary DI / UDI-DI
- 03662724000215 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
neuro|mate® - Frameless Head-holder kit 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 4a75f059-60f0-4bd3-b4d3-c95a4790631d 36 fields · synced May 30, 2026