Identity
- Trade Name
- Nextend | System EUDAMEDBoneFoam FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- Nextend | System EUDAMEDFDA UDI
- Model / Reference
- 104.NPS EUDAMEDFDA UDI
- Description
- Nextend | System FDA UDI
Identifiers
- Catalog Number
- 104.NPS FDA UDI
- Primary DI / UDI-DI
- 00810075280784 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528104NPSDZ EUDAMED
- Direct Marketing DI
- 00810075280784 EUDAMED
- FDA Product Code
- KQZ FDA UDICCX 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
- 888.5890 FDA UDI868.6820 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
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 | System 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 | 081007528104NPSDZ | 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 c260fb68-3024-446c-839b-d6f73e2413af 61 fields · synced Jun 18, 2026
- FDA UDI b80aa09c-80d1-4649-9e3a-660347a11dff 34 fields · synced May 30, 2026