Catalog Number

PUOCNYVB7

Brand Name

CARDINAL HEALTH

Version/Model Number

PUOCNYVB7

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

PPE

Product Code Name

Nephroscope set

Public Device Record Key

91b13ef0-f23c-4dab-8a17-1b99806041d3

Public Version Date

April 22, 2022

Public Version Number

1

DI Record Publish Date

April 14, 2022

Package DI Number

50195594640314

Quantity per Package

1

Contains DI Package

10195594640316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE