Catalog Number

PUOCNYVB5

Brand Name

CARDINAL HEALTH

Version/Model Number

PUOCNYVB5

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

78298a4f-8bc4-4aeb-968a-b30af970d278

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

50888439872581

Quantity per Package

1

Contains DI Package

10888439872583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE