Identity
- Trade Name
- CombiMax FDA UDI
- Generic Name
- Diagnostic X-ray system positioning frame FDA UDI
- Model / Reference
- Right Hand FDA UDI
Identifiers
- Catalog Number
- S 0621 1100RH FDA UDI
- Primary DI / UDI-DI
- B884S06211100R0 FDA UDI
- FDA Product Code
- IZZ FDA UDI
- GMDN Term
- Diagnostic X-ray system positioning frame FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diagnostic X-ray system positioning frame
CombiMax by Pausch, L.L.C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic X-ray system positioning frame.
- Foot and Ankle Stand — Oxos Medical · Class I
- CombiMax — Pausch, L.L.C. · Class II
- ElevatorMax — Pausch, L.L.C. · 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
- Pausch, L.L.C.
Sources (1)
- FDA UDI 78c9d830-293d-4011-981c-3eaf3382b5d6 33 fields · synced May 30, 2026