Catalog Number

VBHR090502A

Brand Name

GORE VIABAHN Endoprosthesis with Heparin

Version/Model Number

VBHR090502A

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P040037,P130006

Product Code

NIP

Product Code Name

Stent, Superficial Femoral Artery

Public Device Record Key

c0c3fcf6-3282-43e3-9d5a-02b0d052abc9

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

August 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-