Catalog Number

SBAOCPPCUB

Brand Name

CARDINAL HEALTH

Version/Model Number

SBAOCPPCUB

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

7f6d5ae1-f896-4c23-8146-de93b3c8b2b4

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

Package DI Number

50888439958728

Quantity per Package

3

Contains DI Package

10888439958720

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE