EluNIR idaforolimus Eluting Coronary Stent System

GUDID 07290107013895

MEDINOL LTD.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Primary Device ID07290107013895
NIH Device Record Key4c963a42-8fc0-421e-ac09-bffdee403c60
Commercial Distribution StatusIn Commercial Distribution
Brand NameEluNIR idaforolimus Eluting Coronary Stent System
Version Model NumberLUN350R12US
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(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@ca
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com

Device Dimensions

Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107013895 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-18

Devices Manufactured by MEDINOL LTD.

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07290107017947 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
07290107017954 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
07290107017961 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
07290107017978 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
07290107017985 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
07290107017992 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
07290107018005 - EluNIR-PERL Ridaforolimus Eluting Coronary Stent System2023-12-25
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