Identity
- Trade Name
- Bore Gauge Alpha Maquet Plus EU FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Collision indicator for transfer during intraoperative brain surgery. FDA UDI
- Model / Reference
- 03 FDA UDI
- Description
- Collision indicator for transfer during intraoperative brain surgery. FDA UDI
Identifiers
- Catalog Number
- 117990 FDA UDI
- Primary DI / UDI-DI
- 04251269206672 FDA UDI
- 510(k) Number
- K133506 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Skull clamp
Bore Gauge Alpha Maquet Plus EU by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skull clamp.
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- DORO® Base Unit — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- DORO® Skull Clamp System — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
- ClearPoint — Clearpoint Neuro, Inc. · Class II
- MAYFIELD® — Integra Lifesciences Corp. · Class II
Cleared under the same submission
K133506 also covers:
- 5 Pin Bolt Wrench (Ball Handle) — NORAS MRI products GmbH
- 5 Pin Bolt Wrench small — NORAS MRI products GmbH
- 5 Pin Bolt Wrench small — NORAS MRI products GmbH
- All-Purpose Arch — NORAS MRI products GmbH
- All-Purpose Arch Adapter — NORAS MRI products GmbH
- All-Purpose Arch Set — NORAS MRI products GmbH
- All-Purpose Arch Set — NORAS MRI products GmbH
- Base Plate — NORAS MRI products GmbH
- Base Plate — NORAS MRI products GmbH
- Bore Gauge Magnus US — NORAS MRI products GmbH
- Bore Gauge Magnus US — NORAS MRI products GmbH
- Bore Gauge TruSystem 7500 EU — NORAS MRI products GmbH
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
- NORAS MRI products GmbH
Sources (1)
- FDA UDI 31cf4222-ab20-4486-b0f0-e8d53b58c246 36 fields · synced Jun 6, 2026