Identity
- Trade Name
- Head Holder FDA UDI
- Generic Name
- Skull clamp FDA UDI
- Device Name
- Head Holder, (Radiolucent) FDA UDI
- Model / Reference
- 07-985-06 FDA UDI
- Description
- Head Holder, (Radiolucent) FDA UDI
Identifiers
- Catalog Number
- 07-985-06 FDA UDI
- Primary DI / UDI-DI
- 04946329064667 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 — 290 Millimeter FDA UDI
Category: Skull clamp
Head Holder by Mizuho Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mizuho Corporation
Sources (2)
- FDA UDI 04dce2a2-84c5-4e56-ba9c-b9cbd3b19d2e 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026