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EluNIR-PERL Ridaforolimus Eluting Coronary Stent System
FDA UDIClass III (US FDA UDI)
by Medinol Ltd.
Identity
- Trade Name
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System FDA UDI
- Generic Name
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
- Model / Reference
- ELM400R33US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290107015622 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
- 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 33 Millimeter FDA UDILumen/Inner Diameter — 4.0 Millimeter FDA UDI
Category: Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System by Medinol Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated.
- XIENCE Sierra™ — Abbott Vascular · Class III
- SYNERGY™ XD — Boston Scientific · Class III
- SYNERGY™ XD — Boston Scientific · Class III
- Resolute Integrity™ — MEDTRONIC, INC. · Class III
- Resolute Onyx™ — MEDTRONIC, INC. · Class III
- Resolute Integrity™ — MEDTRONIC, INC. · Class III
- XIENCE Sierra™ — Abbott Vascular · Class III
- Resolute Integrity™ — MEDTRONIC, INC. · Class III
Cleared under the same submission
P170008 also covers:
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System — MEDINOL LTD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Medinol Ltd.
Sources (1)
- FDA UDI c6e97b0f-9fa9-4aea-a6d4-fd8bef11b1a8 36 fields · synced May 30, 2026