EluNIR Ridaforolimus Eluting Coronary Stent System

GUDID 07290107013789

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 ID07290107013789
NIH Device Record Key3267488f-a27b-468a-b449-fa3ded85e31f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEluNIR Ridaforolimus Eluting Coronary Stent System
Version Model NumberLUN350R38US
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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
Phone(800) 327-7714
EmailGMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com

Device Dimensions

Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length38 Millimeter
Lumen/Inner Diameter3.5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
Special Storage Condition, SpecifyBetween 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107013789 [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 Date2020-01-17
Device Publish Date2020-01-09

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

07290107013994LUN300R28US
07290107013970LUN300R33US
07290107013963LUN400R33US
07290107013949LUN400R28US
07290107013918LUN350R08US
07290107013901LUN400R20US
07290107013888LUN400R17US
07290107013871LUN350R15US
07290107013864LUN400R15US
07290107013857LUN350R17US
07290107013840LUN400R12US
07290107013833LUN350R20US
07290107013826LUN400R08US
07290107013819LUN350R24US
07290107013796LUN350R28US
07290107013765LUN350R33US
07290107013758LUN250R08US
07290107013741LUN300R24US
07290107013734LUN300R20US
07290107013727LUN300R17US
07290107013598LUN275R08US
07290107013581LUN250R33US
07290107013567LUN250R24US
07290107013550LUN250R20US
07290107013987LUN400R38US
07290107013956LUN300R38US
07290107013789LUN350R38US
07290107014595LUN400R38US
07290107014588LUN350R38US
07290107014571LUN300R38US
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