Identity
- Trade Name
- neuro|mate® - Bone fixation drill 3mm FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- The drill is used to create a hole in the patient's skull to screw the temporary implant insert. FDA UDI
- Model / Reference
- Fiducial fixation kit FDA UDI
- Description
- The drill is used to create a hole in the patient's skull to screw the temporary implant insert. FDA UDI
Identifiers
- Catalog Number
- 039.0345 FDA UDI
- Primary DI / UDI-DI
- 03662724000161 FDA UDI
- 510(k) Number
- K132755 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
neuro|mate® - Bone fixation drill 3mm by Renishaw Mayfield — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K132755 also covers:
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool guide — RENISHAW MAYFIELD
- neuromate tool-holder — RENISHAW MAYFIELD
- neuro|mate® - Adaptation for CRW Integra frame — RENISHAW MAYFIELD
- neuro|mate® - Adaptation for Leksell Model G Elekta frame — RENISHAW MAYFIELD
- neuro|mate® - Laser tool-holder — RENISHAW MAYFIELD
- neuro|mate® - Registration frame — RENISHAW MAYFIELD
- neuro|mate® - Tool-holder fixation screw — RENISHAW MAYFIELD
- neuro|mate® - Tool-holder locking screw — RENISHAW MAYFIELD
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 e1fed502-52eb-4f0f-8133-19952118c7ea 37 fields · synced May 30, 2026