Catalog Number

PGV2CR34M

Brand Name

CARDINAL HEALTH

Version/Model Number

PGV2CR34M

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

NWU

Product Code Name

Endoscope introducer kit

Public Device Record Key

a66dd475-e129-4b8b-8129-f4e0407de2ce

Public Version Date

August 25, 2020

Public Version Number

1

DI Record Publish Date

August 17, 2020

Package DI Number

50888439848746

Quantity per Package

1

Contains DI Package

10888439848748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE