Duns Number:600593800
Catalog Number
-
Brand Name
EluNIR Ridaforolimus Eluting Coronary Stent System
Version/Model Number
LUN400R24US
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
078fc61b-4855-4dd9-980f-ea36153668d2
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 83 |
3 | A medical device with high risk that requires premarket approval | 89 |