Identity
- Trade Name
- neuro|mate® - CT Scanner Localizer FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- The imaging localizer is attached to the temporary implant insert when the patient goes into the CT scanner for use in the ultrasound Frameless mode. Delivered in a storage case. FDA UDI
- Model / Reference
- Localizer FDA UDI
- Description
- The imaging localizer is attached to the temporary implant insert when the patient goes into the CT scanner for use in the ultrasound Frameless mode. Delivered in a storage case. FDA UDI
Identifiers
- Catalog Number
- 001.0010 FDA UDI
- Primary DI / UDI-DI
- 03662724000116 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
neuro|mate® - CT Scanner Localizer 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 6165f914-fe0a-4640-a394-0a153841d63f 36 fields · synced May 30, 2026