Catalog Number

-

Brand Name

AFX2 Bifurcated Endograft System

Version/Model Number

BEA25-40/I16-40

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

P040002,P040002

Product Code

MIH

Product Code Name

System, Endovascular Graft, Aortic Aneurysm Treatment

Public Device Record Key

ee8b1108-b31b-4f00-9dde-27ae4c1ac90f

Public Version Date

April 08, 2022

Public Version Number

7

DI Record Publish Date

January 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-