Catalog Number

28-B2-28-120U

Brand Name

TREO Abdominal Stent-Graft System

Version/Model Number

28-B2-28-120U

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

P190015

Product Code

MIH

Product Code Name

System, Endovascular Graft, Aortic Aneurysm Treatment

Public Device Record Key

8122b376-bcf4-4d01-b7ee-abb8bd0301ed

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

May 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-