Catalog Number

-

Brand Name

EluNIRTM Ridaforolimus Eluting Coronary Stent System

Version/Model Number

LUN225L33US

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

7b0d7617-6962-45c1-9f85-e0d10bf98fcf

Public Version Date

October 28, 2022

Public Version Number

1

DI Record Publish Date

October 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-