Catalog Number

SBA19LCKH4

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA19LCKH4

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

cf77f111-085b-44ce-89df-184ae4b1c838

Public Version Date

January 12, 2022

Public Version Number

1

DI Record Publish Date

January 04, 2022

Package DI Number

50195594482051

Quantity per Package

2

Contains DI Package

10195594482053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE