EluNIR Ridaforolimus Eluting Coronary Stent Syste

GUDID 07290107013529

MEDINOL LTD.

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

• Primary Device ID: 07290107013529
• NIH Device Record Key: 5608ab5b-36c3-4bc3-ba4d-8b3dee4055a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EluNIR Ridaforolimus Eluting Coronary Stent Syste
• Version Model Number: LUN250R12US
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 327-7714
• Email: GMB-CORDIS-CUSTOMER-SUPPORT@ca
• 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: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com
• Phone: (720) 386 5585
• Email: customerservice@medinol.com

Device Dimensions

• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter
• Lumen/Inner Diameter: 2.5 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107013529 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-18

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

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