EluNIR-PERL Ridaforolimus Eluting Coronary Stent System

GUDID 07290107015325

MEDINOL LTD.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Primary Device ID07290107015325
NIH Device Record Keybee23245-7444-4add-8ce9-fc4c52424faa
Commercial Distribution StatusIn Commercial Distribution
Brand NameEluNIR-PERL Ridaforolimus Eluting Coronary Stent System
Version Model NumberELM275R20US
Company DUNS600593800
Company NameMEDINOL LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com
Phone(720) 386 5585
Emailcustomerservice@medinol.com

Device Dimensions

Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length20 Millimeter
Lumen/Inner Diameter2.75 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107015325 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NIQCoronary Drug-Eluting Stent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-10

On-Brand Devices [EluNIR-PERL Ridaforolimus Eluting Coronary Stent System]

07290107015639ELM400R38US
07290107015622ELM400R33US
07290107015615ELM400R28US
07290107015608ELM400R24US
07290107015592ELM400R20US
07290107015585ELM400R17US
07290107015578ELM400R15US
07290107015561ELM400R12US
07290107015554ELM400R08US
07290107015547ELM350R38US
07290107015530ELM350R33US
07290107015523ELM350R28US
07290107015516ELM350R24US
07290107015509ELM350R20US
07290107015493ELM350R17US
07290107015486ELM350R15US
07290107015479ELM350R12US
07290107015462ELM350R08US
07290107015455ELM300R38US
07290107015448ELM300R33US
07290107015431ELM300R28US
07290107015424ELM300R24US
07290107015417ELM300R20US
07290107015400ELM300R17US
07290107015394ELM300R15US
07290107015387ELM300R12US
07290107015370ELM300R08US
07290107015363ELM275R38US
07290107015356ELM275R33US
07290107015349ELM275R28US
07290107015332ELM275R24US
07290107015325ELM275R20US
07290107015318ELM275R17US
07290107015301ELM275R15US
07290107015295ELM275R12US
07290107015288ELM275R08US
07290107015271ELM250R33US
07290107015264ELM250R28US
07290107015257ELM250R24US
07290107015240ELM250R20US
07290107015233ELM250R17US
07290107015226ELM250R15US
07290107015219ELM250R12US
07290107015202ELM250R08US
07290107018005ELM225R33US
07290107017992ELM225R28US
07290107017985ELM225R24US
07290107017978ELM225R20US
07290107017961ELM225R17US
07290107017954ELM225R15US

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