Catalog Number

ZTA-DE-20-148-W

Brand Name

Zenith Alpha

Version/Model Number

G35505

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2017

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

P140016

Product Code

MIH

Product Code Name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Public Device Record Key

88521d58-d67f-42f7-b9c7-0e0f9fe5c20e

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-