Catalog Number

SCV30THRHL

Brand Name

CARDINAL HEALTH

Version/Model Number

SCV30THRHL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 19, 2017

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"

-

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

d558f77e-bbcc-4b83-bbb7-457d2f0316e1

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2015

Package DI Number

50885425963599

Quantity per Package

3

Contains DI Package

00885425963594

Package Discontinue Date

October 19, 2017

Package Status

Not in Commercial Distribution

Package Type

CASE