Catalog Number

PUOCNYVBW

Brand Name

CARDINAL HEALTH

Version/Model Number

PUOCNYVBW

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

fbad1426-25cd-4908-adc9-39ad36934f49

Public Version Date

December 31, 2018

Public Version Number

1

DI Record Publish Date

November 30, 2018

Package DI Number

50888439124345

Quantity per Package

1

Contains DI Package

10888439124347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE