Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Operating table traction frame FDA UDI
- Device Name
- UED-OR Table Traction Frame EUDAMEDSchlein Hand Positioner FDA UDI
- Model / Reference
- A-20750 EUDAMED101004 FDA UDI
- Description
- Schlein Hand Positioner FDA UDI
Identifiers
- Catalog Number
- A-20750 FDA UDI
- Primary DI / UDI-DI
- 00615521001506 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN1010047D EUDAMED
- FDA Product Code
- HST FDA UDI
- EMDN Code
- Z12130285 ORTHOPAEDIC TRACTION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Operating table traction frame FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5850 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
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
Yes
FDA UDI
Allen by Hill-Rom, 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 | 0615521GMN1010047D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (2)
- EUDAMED 79a2607e-73bc-4eeb-94d4-59ab4ebaf167 61 fields · synced Jul 16, 2026
- FDA UDI dfc6e00f-e602-4492-ba0d-ad409d92db2d 35 fields · synced May 30, 2026