Catalog Number

PHA061001A

Brand Name

TIGRIS Vascular Stent

Version/Model Number

PHA061001A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P160004

Product Code

NIP

Product Code Name

Stent, Superficial Femoral Artery

Public Device Record Key

df8466ac-6f41-4df1-bcb7-8c63270cc5db

Public Version Date

April 08, 2022

Public Version Number

9

DI Record Publish Date

August 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-