EluNIR Ridaforolimus Eluting Coronary Stent System

GUDID 07290107013673

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 ID07290107013673
NIH Device Record Keya52c584a-6946-4c25-9055-5a2837d49a93
Commercial Distribution StatusIn Commercial Distribution
Brand NameEluNIR Ridaforolimus Eluting Coronary Stent System
Version Model NumberLUN275R38US
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@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 Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter
Length38 Millimeter
Lumen/Inner Diameter2.75 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107013673 [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]

07290107013673LUN275R38US
07290107014564LUN275R38US
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