Identity
- Trade Name
- Nextend | Lite EUDAMEDBoneFoam FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- Nextend | Lite EUDAMEDFDA UDI
- Model / Reference
- 104.NPL EUDAMEDFDA UDI
- Description
- Nextend | Lite FDA UDI
Identifiers
- Catalog Number
- 104.NPL FDA UDI
- Primary DI / UDI-DI
- 00810075281491 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528104NPLDK EUDAMED
- Direct Marketing DI
- 00810075281491 EUDAMED
- FDA Product Code
- CCX FDA UDIKQZ FDA UDI
- EMDN Code
- V080302,V0880 EUDAMED
- GMDN Term
- Operating table patient positioning set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI888.5890 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
Nextend | Lite 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 | 081007528104NPLDK | 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 4e313e9c-70c2-48a4-a009-7ec871380097 61 fields · synced Jul 9, 2026
- FDA UDI d2429c84-b14c-4e87-936c-e84dc650c171 34 fields · synced May 30, 2026