Catalog Number

28-C2-30-040U

Brand Name

TREO Abdominal Stent-Graft System

Version/Model Number

28-C2-30-040U

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

2f2d83bd-ffc0-41b7-b17a-cf0c08a95ff1

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

-