Catalog Number

SBA56GSIHA

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA56GSIHA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

00af5f10-df01-4e1a-a373-bdeb1b29bcd5

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

August 09, 2016

Package DI Number

50887488534884

Quantity per Package

10

Contains DI Package

10887488534886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE