Catalog Number

SAN11ANKIK

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN11ANKIK

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

aba5d5a7-215d-454b-bc41-8e41279bac3f

Public Version Date

July 23, 2018

Public Version Number

3

DI Record Publish Date

July 05, 2016

Package DI Number

50885425992131

Quantity per Package

2

Contains DI Package

10885425992133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE