Identity
- Trade Name
- SBH FDA UDI
- Generic Name
- Neurosurgical headrest FDA UDI
- Device Name
- MF-Swivel Adaptor FDA UDI
- Model / Reference
- MF - Swivel Adaptor FDA UDI
- Description
- MF-Swivel Adaptor FDA UDI
Identifiers
- Catalog Number
- SBH 117-000-25 FDA UDI
- Primary DI / UDI-DI
- 00850068304165 FDA UDI
- FDA Product Code
- HBM FDA UDI
- GMDN Term
- Neurosurgical headrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.4440 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Neurosurgical headrest
Sbh by SBH Surgical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DORO® Horseshoe RS — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
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- DORO LUCENT® iMRI Pad — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- DORO® Horseshoe ENT — pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung · Class II
- Schaerer Medical USA — Schaerer Medical Usa, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- SBH Surgical
Sources (1)
- FDA UDI 780aebe9-2fdb-4b50-acb4-396328b4c14f 35 fields · synced Jun 8, 2026