Catalog Number

142122-09

Brand Name

BioMimics 3D Vascular Stent System

Version/Model Number

142122-09

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 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

-

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

-

FDA Premarket Submission

P180003

Product Code

NIP

Product Code Name

Stent, Superficial Femoral Artery

Public Device Record Key

4425cf47-b7ba-4097-adb6-864e6686a5e3

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

August 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-