Birkova - Surgical Table Pad Set, PC for Skytron Elite - STERIS CORPORATION

Duns Number:036985604

Device Description: Surgical Table Pad Set, PC for Skytron Elite 3500, 3500B

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More Product Details

Catalog Number

PC7035

Brand Name

Birkova

Version/Model Number

Table Pads

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LWG

Product Code Name

SURGICAL TABLE CUSHION

Device Record Status

Public Device Record Key

d31a748f-6422-413d-aba3-3b5070c92e84

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERIS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1528
2 A medical device with a moderate to high risk that requires special controls. 1557