EluNIR-PERL Ridaforolimus Eluting Coronary Stent System

GUDID 07290107015219

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 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 ID: 07290107015219
• NIH Device Record Key: c4497342-e488-4770-9c8d-a154fe8cb634
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EluNIR-PERL Ridaforolimus Eluting Coronary Stent System
• Version Model Number: ELM250R12US
• 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: (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

• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor
• Special Storage Condition, Specify: Between 0 and 0 *Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F). edit record icondelete recor

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107015219 [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: 2023-12-18
• Device Publish Date: 2023-12-10

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

• 07290107015639: ELM400R38US
• 07290107015622: ELM400R33US
• 07290107015615: ELM400R28US
• 07290107015608: ELM400R24US
• 07290107015592: ELM400R20US
• 07290107015585: ELM400R17US
• 07290107015578: ELM400R15US
• 07290107015561: ELM400R12US
• 07290107015554: ELM400R08US
• 07290107015547: ELM350R38US
• 07290107015530: ELM350R33US
• 07290107015523: ELM350R28US
• 07290107015516: ELM350R24US
• 07290107015509: ELM350R20US
• 07290107015493: ELM350R17US
• 07290107015486: ELM350R15US
• 07290107015479: ELM350R12US
• 07290107015462: ELM350R08US
• 07290107015455: ELM300R38US
• 07290107015448: ELM300R33US
• 07290107015431: ELM300R28US
• 07290107015424: ELM300R24US
• 07290107015417: ELM300R20US
• 07290107015400: ELM300R17US
• 07290107015394: ELM300R15US
• 07290107015387: ELM300R12US
• 07290107015370: ELM300R08US
• 07290107015363: ELM275R38US
• 07290107015356: ELM275R33US
• 07290107015349: ELM275R28US
• 07290107015332: ELM275R24US
• 07290107015325: ELM275R20US
• 07290107015318: ELM275R17US
• 07290107015301: ELM275R15US
• 07290107015295: ELM275R12US
• 07290107015288: ELM275R08US
• 07290107015271: ELM250R33US
• 07290107015264: ELM250R28US
• 07290107015257: ELM250R24US
• 07290107015240: ELM250R20US
• 07290107015233: ELM250R17US
• 07290107015226: ELM250R15US
• 07290107015219: ELM250R12US
• 07290107015202: ELM250R08US
• 07290107018005: ELM225R33US
• 07290107017992: ELM225R28US
• 07290107017985: ELM225R24US
• 07290107017978: ELM225R20US
• 07290107017961: ELM225R17US
• 07290107017954: ELM225R15US