Identity
- Trade Name
- Nextend | Lite | Single Use Kit EUDAMEDBoneFoam FDA UDI
- Generic Name
- Operating table patient positioning set, single-use FDA UDI
- Device Name
- Nextend | Lite | Single Use Kit EUDAMEDNextend | Lite | Single Use Kit | Box of 5 FDA UDI
- Model / Reference
- 104.NPL-SUK EUDAMED104.NPL-SUK-BX5 FDA UDI
- Description
- Nextend | Lite | Single Use Kit | Box of 5 FDA UDI
Identifiers
- Catalog Number
- 104.NPL-SUK-BX5 FDA UDI
- Primary DI / UDI-DI
- 00810075281521 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528104NPLSUKY6 EUDAMED
- FDA Product Code
- KQZ FDA UDI
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMED
- GMDN Term
- Operating table patient positioning set, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5890 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
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
Nextend | Lite | Single Use Kit 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 | 081007528104NPLSUKY6 | 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 0ea043e4-bb70-4269-a5a5-320144bad2df 61 fields · synced Jul 11, 2026
- FDA UDI d981ee8e-2502-4ea3-b1e6-117637b6d300 34 fields · synced May 30, 2026