Identity
- Trade Name
- Adjust. UAS set/2 FDA UDI
- Generic Name
- Indexed-immobilization patient positioning system FDA UDI
- Device Name
- Height adjustable arm support with flexible high armcup fit for OmniBoard, MultiBoard, BreastBoard SX, set of 2 FDA UDI
- Model / Reference
- DSCP-AAS FDA UDI
- Description
- Height adjustable arm support with flexible high armcup fit for OmniBoard, MultiBoard, BreastBoard SX, set of 2 FDA UDI
Identifiers
- Catalog Number
- 125320 FDA UDI
- Primary DI / UDI-DI
- 08719425704326 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Indexed-immobilization patient positioning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Indexed-immobilization patient positioning system
Adjust. UAS set/2 by Macromedics B.v. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Macromedics B.v.
Sources (2)
- FDA UDI 6bf750ed-1596-492e-b260-370813ea45b7 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026