EluNIR Ridaforolimus Eluting Coronary Stent Syste

GUDID 07290107013529

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 ID07290107013529
NIH Device Record Key5608ab5b-36c3-4bc3-ba4d-8b3dee4055a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameEluNIR Ridaforolimus Eluting Coronary Stent Syste
Version Model NumberLUN250R12US
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

Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter
Lumen/Inner Diameter2.5 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107290107013529 [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

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

07290107013925LUN400R24US
07290107013710LUN300R15US
07290107013703LUN300R12US
07290107013697LUN300R08US
07290107013666LUN275R33US
07290107013659LUN275R28US
07290107013642LUN275R24US
07290107013635LUN275R20US
07290107013628LUN275R17US
07290107013611LUN275R15US
07290107013604LUN275R12US
07290107013574LUN250R28US
07290107013543LUN250R17US
07290107013536LUN250R15US
07290107013529LUN250R12US

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