Catalog Number

SOT33PNOU6

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT33PNOU6

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

399d01bd-e93a-4321-be14-a4e18c26f74f

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Package DI Number

50195594349385

Quantity per Package

1

Contains DI Package

10195594349387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE