Catalog Number

CXT231412

Brand Name

GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral

Version/Model Number

CXT231412

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

P200030

Product Code

MIH

Product Code Name

System, Endovascular Graft, Aortic Aneurysm Treatment

Public Device Record Key

8031d005-227a-48c2-9a90-db00b520cf55

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

February 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-