Identity
- Trade Name
- Neuro Adapter Bar EUDAMEDNeuro Adapter D850 FDA UDI
- Generic Name
- ENT headrest FDA UDI
- Device Name
- Surgical Table Accessory EUDAMEDNeuro Adapter D850 OZ 7520675, High Profile FDA UDI
- Model / Reference
- OZ 7520675 EUDAMEDFDA UDI
- Description
- Neuro Adapter D850 OZ 7520675, High Profile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863106000417 EUDAMEDFDA UDI
- Basic UDI-DI
- 008631060000448ZQ EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- ENT headrest FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Belgium 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Neuro Adapter Bar by P and G Engineering, Incorporated — 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 | 008631060000448ZQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- P and G Engineering, Incorporated
- EUDAMED SRN
- US-MF-000004658
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED 9fc6d9a0-b53e-4ee8-9f22-3fc1f1bec8d9 61 fields · synced Jun 18, 2026
- FDA UDI acc7a781-940c-40ab-a44d-dd3bd3fac3ee 33 fields · synced May 30, 2026