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Wedge | Left Upper Extremity | Large
EUDAMEDFDA UDIClass I (EU MDR)
Ref 925.LUEWL
Identity
- Trade Name
- Wedge | Left Upper Extremity | Large EUDAMEDBoneFoam FDA UDI
- Generic Name
- Freestanding patient positioner, reusable FDA UDI
- Device Name
- Wedge | Left Upper Extremity | Large EUDAMEDFDA UDI
- Model / Reference
- 925.LUEWL EUDAMEDFDA UDI
- Description
- Wedge | Left Upper Extremity | Large FDA UDI
Identifiers
- Catalog Number
- 925.LUEWL FDA UDI
- Primary DI / UDI-DI
- 00810075280401 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528925LUEWLSM EUDAMED
- Direct Marketing DI
- 00810075280401 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Freestanding patient positioner, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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
No
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 24 Inch FDA UDIHeight — 11.63 Inch FDA UDI
Wedge | Left Upper Extremity | Large by Bone Foam, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081007528925LUEWLSM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bone Foam, Inc.
- EUDAMED SRN
- US-MF-000035043
- Authorised Representative
- Bone Foam B.V. NL-AR-000035735
Sources (2)
- EUDAMED bd666eee-cac4-460e-a950-cbcf49d8e749 61 fields · synced Jun 19, 2026
- FDA UDI e4c448fb-f9cc-4b75-b1ce-a36c894cfa04 35 fields · synced May 30, 2026