Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Surgical linen/cushion set FDA UDI
- Device Name
- RSP-LINEN OR CUSHION SET EUDAMEDALLEN ULTRA COMFORT COVERS SMALL 1 PC. FDA UDI
- Model / Reference
- A-71261 EUDAMED107006 FDA UDI
- Description
- ALLEN ULTRA COMFORT COVERS SMALL 1 PC. FDA UDI
Identifiers
- Catalog Number
- 750279 FDA UDI
- Primary DI / UDI-DI
- 00615521030919 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN1070068T EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical linen/cushion set FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Category: Surgical retraction system, reusable
Allen by Hill-Rom, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
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- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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 | 0615521GMN1070068T | 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 f6edffdf-9054-41bb-a2d3-512fd8ac2013 61 fields · synced Jul 14, 2026
- FDA UDI 1d7b3401-cfb5-46d0-9ce0-79e1232a670a 35 fields · synced May 30, 2026