Catalog Number

PV35OTS16

Brand Name

CARDINAL HEALTH

Version/Model Number

PV35OTS16

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

e56faead-8354-4fd7-8a9a-713eb659e7c6

Public Version Date

March 28, 2019

Public Version Number

1

DI Record Publish Date

March 20, 2019

Package DI Number

50888439429075

Quantity per Package

1

Contains DI Package

10888439429077

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE