Catalog Number

SOT23NPSE5

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT23NPSE5

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

PPE

Product Code Name

Nephroscope set

Public Device Record Key

b6865a6c-9b9e-4888-add1-f9b1609f8e07

Public Version Date

June 04, 2021

Public Version Number

1

DI Record Publish Date

May 27, 2021

Package DI Number

50195594123022

Quantity per Package

10

Contains DI Package

10195594123024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE