Catalog Number

-

Brand Name

Exodus

Version/Model Number

10529

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

K152069

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

f1b91eee-aa7e-4712-9894-1ae1432704d6

Public Version Date

August 26, 2021

Public Version Number

4

DI Record Publish Date

August 03, 2016

Package DI Number

H965105291

Quantity per Package

5

Contains DI Package

H965105290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX