Identity
- Trade Name
- Prime Medical LLC FDA UDI
- Generic Name
- Operating table non-slip back pad FDA UDI
- Device Name
- PrimePad-1 EUDAMED
- Model / Reference
- PrimePad-2 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- PrimePad-2 FDA UDI
- Primary DI / UDI-DI
- 00855085005521 EUDAMEDFDA UDI
- Basic UDI-DI
- 0855085005PrimePadGJ EUDAMED
- Direct Marketing DI
- 00855085005521 EUDAMED
- FDA Product Code
- LWG FDA UDI
- EMDN Code
- V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED
- GMDN Term
- Operating table non-slip back pad FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- Denmark 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
PrimePad-1 by Prime Medical LLC — 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 | 0855085005PrimePadGJ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Prime Medical LLC
- EUDAMED SRN
- US-MF-000015557
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (2)
- EUDAMED 9f3dd9f6-40a3-490e-b6e9-d4d0031236c7 61 fields · synced Jun 18, 2026
- FDA UDI 55a3aaa5-43e3-4dbe-8640-0e686d65631d 33 fields · synced May 30, 2026