Identity
- Trade Name
- neuro|mate® - Fiducial fixation Kit FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- The kit is only used for the ultrasound Frameless registration. The fiducial fixation kit comprises a temporary implant insert, a screwdriverfor the temporary implant insert, four pins, a screwdriver for the pins, a drill, a stop collar, a screwdriver for the stop collar and a sterilization container. FDA UDI
- Model / Reference
- Fiducial fixation kit FDA UDI
- Description
- The kit is only used for the ultrasound Frameless registration. The fiducial fixation kit comprises a temporary implant insert, a screwdriverfor the temporary implant insert, four pins, a screwdriver for the pins, a drill, a stop collar, a screwdriver for the stop collar and a sterilization container. FDA UDI
Identifiers
- Catalog Number
- 001.0017 FDA UDI
- Primary DI / UDI-DI
- 03662724000130 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
neuro|mate® - Fiducial fixation 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 1a3ffb24-c3d4-4dca-8803-9bf366fac0e6 35 fields · synced Jun 6, 2026