Catalog Number

SOT4AMUJHI

Brand Name

CARDINAL HEALTH

Version/Model Number

SOT4AMUJHI

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"

-

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

NWU

Product Code Name

Kit, introducer, endoscope

Public Device Record Key

aa46354c-d432-470a-9a08-9de82b72436e

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 13, 2015

Package DI Number

50887488042419

Quantity per Package

2

Contains DI Package

00887488042414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE