Identity
- Trade Name
- FusionMAX FDA UDI
- Generic Name
- Neurosurgical headrest FDA UDI
- Device Name
- FusionMAX Head Rest Support- plastic headrest for prone positioning. Designed to be used in conjunction with prone pillow. Attached to head of surgical table with locking peg system FDA UDI
- Model / Reference
- 33501-17-000 FDA UDI
- Description
- FusionMAX Head Rest Support- plastic headrest for prone positioning. Designed to be used in conjunction with prone pillow. Attached to head of surgical table with locking peg system FDA UDI
Identifiers
- Catalog Number
- 33501-17-000 FDA UDI
- Primary DI / UDI-DI
- 00840343716660 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Neurosurgical headrest FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurosurgical headrest
FusionMAX by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
- Surgix Medical Llc
Sources (1)
- FDA UDI acd4115d-9c0c-47ee-ade0-9899cff1adbe 35 fields · synced May 30, 2026