Catalog Number

SBA68LPVAK

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA68LPVAK

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

731d18cd-b85e-41b9-ac0d-7090367e2032

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

July 17, 2015

Package DI Number

50885425942402

Quantity per Package

1

Contains DI Package

00885425942407

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE