Catalog Number

-

Brand Name

Exodus

Version/Model Number

10424

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

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

3cee996b-8957-46da-854f-53ac5cbe9813

Public Version Date

August 26, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2015

Package DI Number

H965104241

Quantity per Package

5

Contains DI Package

H965104240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX