Identity
- Trade Name
- Nextend | Scapula Bolster EUDAMEDBoneFoam FDA UDI
- Generic Name
- Operating table patient positioning set, reusable FDA UDI
- Device Name
- Nextend | Scapula Bolster EUDAMEDFDA UDI
- Model / Reference
- 104.NPS-SB EUDAMEDFDA UDI
- Description
- Nextend | Scapula Bolster FDA UDI
Identifiers
- Catalog Number
- 104.NPS-SB FDA UDI
- Primary DI / UDI-DI
- 00810075280807 EUDAMEDFDA UDI
- Basic UDI-DI
- 081007528104NPSSBM7 EUDAMED
- Direct Marketing DI
- 00810075280807 EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Operating table patient positioning set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 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
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
Nextend | Scapula Bolster 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 | 081007528104NPSSBM7 | 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 1912c097-c14a-4190-b4a7-d88007e91278 61 fields · synced Jun 18, 2026
- FDA UDI 5f7e3ffa-0775-4225-9f7a-379dec4d8a5e 34 fields · synced May 30, 2026