Catalog Number

SANCGCDA18

Brand Name

CARDINAL HEALTH

Version/Model Number

SANCGCDA18

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

3abf506a-dbaf-4f5d-b744-34fe71a79252

Public Version Date

June 23, 2022

Public Version Number

1

DI Record Publish Date

June 15, 2022

Package DI Number

50195594721488

Quantity per Package

3

Contains DI Package

10195594721480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE