Catalog Number

SBA31DPUIA

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA31DPUIA

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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

b4343eb2-9077-4eb8-858d-7620af2b72c6

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2021

Package DI Number

50888439962664

Quantity per Package

20

Contains DI Package

10888439962666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE