Catalog Number

-

Brand Name

Aorfix AAA Stent Graft Plug In Leg with Aorflex Delivery System

Version/Model Number

SG-HBL-98-18-A13-20

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

P110032

Product Code

MIH

Product Code Name

System, Endovascular Graft, Aortic Aneurysm Treatment

Public Device Record Key

cce29ba6-f772-470a-a7d5-92ad1596e82a

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

April 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-