Catalog Number

-

Brand Name

EluNIR Ridaforolimus Eluting Coronary Stent System

Version/Model Number

LUN400R20US

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"

Yes

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

P170008

Product Code

NIQ

Product Code Name

Coronary Drug-Eluting Stent

Public Device Record Key

4b52c490-9ae4-4622-a335-89fcce75f79a

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

December 18, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-