Identity
- Trade Name
- Universal Prone | Small EUDAMEDBoneFoam FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Universal Prone | Small EUDAMEDFDA UDI
- Model / Reference
- 925.UPS-S EUDAMEDFDA UDI
- Description
- Universal Prone | Small FDA UDI
Identifiers
- Catalog Number
- 925.UPS-S FDA UDI
- Primary DI / UDI-DI
- 00810075281354 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528925UPSSMB EUDAMED
- Direct Marketing DI
- 00810075281354 EUDAMED
- FDA Product Code
- CCX FDA UDIPUI FDA UDI
- EMDN Code
- T030199,V080302 EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI878.4370 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
Yes
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
- Width — 17 Inch FDA UDILength — 33.5 Inch FDA UDI
Universal Prone | Small 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 | 081007528925UPSSMB | 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 a655df61-a20f-4989-a65e-b9b5fd7a3ef4 61 fields · synced Jun 20, 2026
- FDA UDI 08d46059-e0b2-4eb0-a5a7-e1d77e9d3e89 35 fields · synced May 30, 2026