FDA.reportPublic FDA data

EluNIRTM Ridaforolimus Eluting Coronary Stent System

Primary DI
07290107014663
Brand
EluNIRTM Ridaforolimus Eluting Coronary Stent System
Company
MEDINOL LTD.
Model
LUN225L33US
Published
2022-10-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NIQCoronary Drug-Eluting Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIQCoronary Drug-Eluting StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P170008038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P170008038EluNIR™ Ridaforolimus Eluting Coronary Stent SystemMedinol, Ltd.2017-11-28NIQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107014663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107014663072901070146637290107014663

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coatedA non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Diameter2.25Millimeter
Stent Length33Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(720) 386 5585customerservice@medinol.com

Regulatory Flags#

DUNS number
600593800
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R12US2017-12-18
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R15US2017-12-18
07290107013543EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R17US2017-12-18
07290107013550EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R20US2017-12-18
07290107013567EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R24US2017-12-18
07290107013574EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R28US2017-12-18
07290107013581EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R33US 2017-12-18
07290107013598EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R08US2017-12-18
07290107013604EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R12US2017-12-18
07290107013611EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R15US 2017-12-18
07290107013628EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R17US2017-12-18
07290107013635EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R20US2017-12-18
07290107013642EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R24US2017-12-18
07290107013659EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R28US2017-12-18
07290107013666EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R33US 2017-12-18
07290107013697EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R08US2017-12-18
07290107013703EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R12US2017-12-18
07290107013710EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R15US 2017-12-18
07290107013727EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R17US 2017-12-18
07290107013734EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R20US2017-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290107017930EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017947EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017954EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017961EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017978EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017985EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107017992EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
07290107018005EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-17
08717648231261XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231278XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231285XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231308XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
08717648231315XIENCE Skypoint™ABBOTT VASCULAR INC.NIQ2023-12-15
07290107015202EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015219EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015226EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015233EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015240EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015257EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015264EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015271EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015288EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015295EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015301EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015318EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015325EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015332EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015349EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015356EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10
07290107015363EluNIR-PERL Ridaforolimus Eluting Coronary Stent SystemMEDINOL LTD.NIQ2023-12-10