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X-Trans® 24" Double Armboard
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8002067Model Surgical and Diagnostic Devices
by Qfix
Identity
- Trade Name
- X-Trans® 24" Double Armboard FDA UDI
- Generic Name
- Radiological arm/leg positioner FDA UDI
- Device Name
- X-Trans Armboards 24” Double Armboard FDA UDI
- Model / Reference
- 8002067 EUDAMEDFDA UDISurgical and Diagnostic Devices EUDAMED
- Description
- X-Trans Armboards 24” Double Armboard FDA UDI
Identifiers
- Catalog Number
- 8002067 FDA UDI
- Primary DI / UDI-DI
- 10841962110270 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621SURGDXAA EUDAMED
- FDA Product Code
- GDC FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological arm/leg positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 24 Inch FDA UDI
Category: Radiological arm/leg positioner
X-Trans® 24" Double Armboard by Qfix — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological arm/leg positioner.
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- SCANCOAT — DOMICO MED-DEVICE, LLC · 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 35151b87-0fe3-4425-8933-b5e3c71fe3f7 36 fields · synced Jun 19, 2026
- EUDAMED 43228191-d1e8-4a1f-8fe5-890f9bdef515 61 fields · synced Jun 19, 2026