Birkova

FDA UDI

Class I (US FDA UDI)

by Steris Corporation

Identity

Trade Name: Birkova FDA UDI
Generic Name: Operating table mattress, basic FDA UDI
Device Name: Surgical Table Pad Set, PC for Skytron Elite 3500, 3500B FDA UDI
Model / Reference: Table Pads FDA UDI
Description: Surgical Table Pad Set, PC for Skytron Elite 3500, 3500B FDA UDI

Identifiers

Catalog Number: PC7035 FDA UDI
Primary DI / UDI-DI: 00724995212766 FDA UDI
FDA Product Code: LWG FDA UDI
GMDN Term: Operating table mattress, basic 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table mattress, basic

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

Similar devices

Also classified as Operating table mattress, basic.

ALLEN — HILL-ROM, INC. · Class I
ALLEN — HILL-ROM, INC. · Class I
ALLEN — HILL-ROM, INC. · Class I
ALLEN — HILL-ROM, INC. · Class I
PAD, TIBIAL, W/SHEARGUARD, ANDREW, TBL — Mizuho Orthopedic Systems, Inc. · Class I
ARMBOARD — BURLINGTON MEDICAL, LLC · Class I
GE LU PAD SGF — AliMed, LLC · Class I
CT TABLE PAD SGF — AliMed, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Steris Corporation

Sources (1)

FDA UDI d31a748f-6422-413d-aba3-3b5070c92e84 35 fields · synced Jun 8, 2026