EluNIR Ridaforolimus Eluting Coronary Stent System

GUDID 07290107013789

MEDINOL LTD.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

• Primary Device ID: 07290107013789
• NIH Device Record Key: 3267488f-a27b-468a-b449-fa3ded85e31f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EluNIR Ridaforolimus Eluting Coronary Stent System
• Version Model Number: LUN350R38US
• Company DUNS: 600593800
• Company Name: MEDINOL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com

Device Dimensions

• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter
• Length: 38 Millimeter
• Lumen/Inner Diameter: 3.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store at up to 25C/ 77F with transient excursions allowed up to 40C / 104F
• Special Storage Condition, Specify: Between 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 Agency	Device ID
GS1	07290107013789 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170008

FDA Product Code

• NIQ: Coronary Drug-Eluting Stent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-17
• Device Publish Date: 2020-01-09

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

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