Catalog Number

-

Brand Name

EverFlex

Version/Model Number

PRB35-08-150-120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 03, 2015

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

P110023

Product Code

NIP

Product Code Name

STENT, SUPERFICIAL FEMORAL ARTERY

Public Device Record Key

6b964548-5469-484c-8000-2694103cfd50

Public Version Date

April 08, 2022

Public Version Number

6

DI Record Publish Date

May 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-