Catalog Number

SOT33PNOUA

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT33PNOUA

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

075f5708-c4cd-4ef1-a14a-dbda55265e3f

Public Version Date

July 19, 2018

Public Version Number

3

DI Record Publish Date

September 08, 2017

Package DI Number

50887488784449

Quantity per Package

1

Contains DI Package

10887488784441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE