Catalog Number

SOT33PNOU5

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT33PNOU5

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

affc5b61-a4dd-462a-9c79-d54402b8d078

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Package DI Number

50195594287519

Quantity per Package

1

Contains DI Package

10195594287511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE