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EluNIR Ridaforolimus Eluting Coronary Stent System

FDA UDI

Class III (US FDA UDI)

by Medinol Ltd.

Identity

Trade Name
EluNIR Ridaforolimus Eluting Coronary Stent System FDA UDI
Generic Name
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
Model / Reference
LUN300R28US FDA UDI

Identifiers

Primary DI / UDI-DI
07290107013994 FDA UDI
PMA Number
P170008 FDA UDI
FDA Product Code
NIQ FDA UDI
GMDN Term
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 28 Millimeter FDA UDI
Lumen/Inner Diameter — 3.0 Millimeter FDA UDI

EluNIR Ridaforolimus Eluting Coronary Stent System by Medinol Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P170008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medinol Ltd.

Sources (1)

  • FDA UDI 0478828d-0607-4f2d-8963-a50c1ea0d8b9 36 fields · synced May 29, 2026