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Allen

FDA UDI

Class I (US FDA UDI)

by Hill-Rom, Inc.

Identity

Trade Name
ALLEN FDA UDI
Generic Name
Surgical linen/cushion set FDA UDI
Device Name
Radioluc Spine Surgery Frame Stnd Care FDA UDI
Model / Reference
103006 FDA UDI
Description
Radioluc Spine Surgery Frame Stnd Care FDA UDI

Identifiers

Catalog Number
F-70805 FDA UDI
Primary DI / UDI-DI
00615521013028 FDA UDI
FDA Product Code
KME FDA UDI
GMDN Term
Surgical linen/cushion set FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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 linen/cushion set

Allen by Hill-Rom, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical linen/cushion set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hill-Rom, Inc.

Sources (1)

  • FDA UDI 6af7cfd1-f2fe-475d-8f6f-7e1089725e0d 35 fields · synced May 30, 2026