Catalog Number

SAN23PNNCH

Brand Name

CARDINAL HEALTH

Version/Model Number

SAN23PNNCH

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

4dfb4d51-a921-44e7-927d-9dc73f1463e1

Public Version Date

July 17, 2018

Public Version Number

3

DI Record Publish Date

July 23, 2015

Package DI Number

50887488128069

Quantity per Package

6

Contains DI Package

10887488128061

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE