Identity
- Trade Name
- FusionMAX FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- Lower Body Support Plate: removable carbon fiber plate with locking mechanisms. Used in conjunction with cushions to provide support and comfort for patients in prone position FDA UDI
- Model / Reference
- 33501-20-000 FDA UDI
- Description
- Lower Body Support Plate: removable carbon fiber plate with locking mechanisms. Used in conjunction with cushions to provide support and comfort for patients in prone position FDA UDI
Identifiers
- Catalog Number
- 33501-20-000 FDA UDI
- Primary DI / UDI-DI
- 00840343716745 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Operating table patient positioning set, reusable 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: Operating table patient positioning set, reusable
FusionMAX by Surgix Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 3f341227-100a-4da9-8c2f-8b172d60e769 35 fields · synced Jun 1, 2026