Catalog Number

SBA08BARHI

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA08BARHI

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

FDE

Product Code Name

laparoscopy kit

Public Device Record Key

92ddf3a7-ac4b-4c95-a3e8-0cf7b309032b

Public Version Date

April 15, 2021

Public Version Number

1

DI Record Publish Date

April 07, 2021

Package DI Number

50195594960726

Quantity per Package

1

Contains DI Package

10195594960728

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE