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Epidural Positioning Device (EPD Package 2)
EUDAMEDFDA UDIClass I (EU MDR)
Ref EPD Package 2
Identity
- Trade Name
- Epidural Positioning Device (EPD Package 2) EUDAMEDEpidural Positioning Device FDA UDI
- Generic Name
- Head/neck procedure positioner FDA UDI
- Device Name
- Positioning Device EUDAMED
- Model / Reference
- EPD Package 2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850008449550 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850008449EPDPkg2F9 EUDAMED
- Direct Marketing DI
- 00850008449550 EUDAMED
- FDA Product Code
- FWZ FDA UDI
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Head/neck procedure positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4950 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Epidural Positioning Device (EPD Package 2) by Pivotal Health Solutions — 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 | 0850008449EPDPkg2F9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pivotal Health Solutions
- EUDAMED SRN
- US-MF-000042753
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED c7977859-bf42-460f-b5f2-e0f017ff9dd5 61 fields · synced Jun 18, 2026
- FDA UDI 43506198-5508-48f6-99ad-58b0311f5f94 32 fields · synced May 30, 2026