Catalog Number

SBA63LHSE1

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA63LHSE1

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

eef84c4b-4320-4363-962b-77b0ed03f7ca

Public Version Date

March 14, 2019

Public Version Number

1

DI Record Publish Date

March 06, 2019

Package DI Number

50888439406359

Quantity per Package

2

Contains DI Package

10888439406351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE