Catalog Number

VN0806040

Brand Name

GORE VIABIL Biliary Endoprosthesis

Version/Model Number

VN0806040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K081184

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Public Device Record Key

91a9ccf2-fdb5-4bb6-9a5d-09fa69b7289d

Public Version Date

July 22, 2021

Public Version Number

6

DI Record Publish Date

March 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-