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Birkova

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name
Birkova FDA UDI
Generic Name
Arm cushion FDA UDI
Device Name
Armboard Pad 26 inches x 6 inches x 2 inches, Comfort Plus Series FDA UDI
Model / Reference
Table Pads FDA UDI
Description
Armboard Pad 26 inches x 6 inches x 2 inches, Comfort Plus Series FDA UDI

Identifiers

Catalog Number
AS40012CPS FDA UDI
Primary DI / UDI-DI
00724995204334 FDA UDI
FDA Product Code
LWG FDA UDI
GMDN Term
Arm cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Arm cushion

Birkova by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arm cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Steris Corporation

Sources (1)

  • FDA UDI fc47f33f-9ff6-480b-89e0-9ac55639b04a 35 fields · synced Jun 8, 2026