Identity
- Trade Name
- Radiolucent Head Frame FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Head Pin, (Radiolucent, Carbon 2) FDA UDI
- Model / Reference
- 07-986-07 FDA UDI
- Description
- Head Pin, (Radiolucent, Carbon 2) FDA UDI
Identifiers
- Catalog Number
- 07-986-07 FDA UDI
- Primary DI / UDI-DI
- 04946329237344 FDA UDI
- FDA Product Code
- HBL FDA UDI
- GMDN Term
- Skull clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4460 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
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
Dimensions & Sizes
- Size
- Length — 134.5 Millimeter FDA UDI
Category: Skull clamp
Radiolucent Head Frame by Mizuho Corporation — 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
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
- Mizuho Corporation
Sources (1)
- FDA UDI e890d7cd-71ad-47e8-a92b-14d5e4f1caf0 36 fields · synced May 30, 2026