Catalog Number

PV35OTSTE

Brand Name

CARDINAL HEALTH

Version/Model Number

PV35OTSTE

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)

Yes

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

FGA

Product Code Name

Kit, nephroscope

Public Device Record Key

be0db125-c7be-4c85-bcef-d9eb7905ac92

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

January 06, 2017

Package DI Number

50887488608462

Quantity per Package

1

Contains DI Package

10887488608464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE