Catalog Number

PV35OTS11

Brand Name

CARDINAL HEALTH

Version/Model Number

PV35OTS11

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

659f8947-ce8c-45e6-85db-b4bb96d9efe6

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2016

Package DI Number

50887488619208

Quantity per Package

1

Contains DI Package

10887488619200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE