Catalog Number

SAN73CAS16

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN73CAS16

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

OES

Product Code Name

Cardiac catheterization kit

Public Device Record Key

985b16a6-20a6-4fab-b6c5-3b4b8d6d5347

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Package DI Number

50888439869185

Quantity per Package

5

Contains DI Package

10888439869187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE