Catalog Number

SAN21CLAR3

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN21CLAR3

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

OEQ

Product Code Name

Angiography/angioplasty kit

Public Device Record Key

4fd117ab-47f4-48f9-8c2f-14acf656cb33

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

Package DI Number

50888439313688

Quantity per Package

2

Contains DI Package

10888439313680

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE