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Pelvic Cradle | Disposable Barrier Cover | Box of 20
EUDAMEDFDA UDIClass I (EU MDR)
Ref 925.PC-DBC-BX20
Identity
- Trade Name
- Pelvic Cradle | Disposable Barrier Cover | Box of 20 EUDAMEDBoneFoam FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Pelvic Cradle | Disposable Barrier Cover | Box of 20 EUDAMEDFDA UDI
- Model / Reference
- 925.PC-DBC-BX20 EUDAMEDFDA UDI
- Description
- Pelvic Cradle | Disposable Barrier Cover | Box of 20 FDA UDI
Identifiers
- Catalog Number
- 925.PC-DBC-BX20 FDA UDI
- Primary DI / UDI-DI
- 00810075281460 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528925PCDBCMD EUDAMED
- Unit of Use DI
- 00810075281453 EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Pelvic Cradle | Disposable Barrier Cover | Box of 20 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 | 081007528925PCDBCMD | 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 0615d272-9bda-4752-bcb5-ebe8cc05957c 61 fields · synced Oct 6, 2026
- FDA UDI 03f9ed5c-e6fc-4381-a539-2c468765caa4 34 fields · synced May 30, 2026