Catalog Number

SCV13CGBWJ

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV13CGBWJ

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

OEZ

Product Code Name

Cardiovascular procedure kit

Public Device Record Key

ef5c73a9-c6c1-421f-9971-0c0623930001

Public Version Date

July 20, 2018

Public Version Number

3

DI Record Publish Date

July 23, 2015

Package DI Number

50885425963476

Quantity per Package

10

Contains DI Package

00885425963471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE