EluNIRTM Ridaforolimus Eluting Coronary Stent System

GUDID 07290107016698

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

• Primary Device ID: 07290107016698
• NIH Device Record Key: ac7d0380-359d-42f0-81ca-ebc7bdde710e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EluNIRTM Ridaforolimus Eluting Coronary Stent System
• Version Model Number: LUN225L15US
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter
• Stent Diameter: 2.25 Millimeter
• Stent Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290107016698 [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: 2022-10-28
• Device Publish Date: 2022-10-20

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

• 07290107016735: LUN225L28US
• 07290107016728: LUN225L24US
• 07290107016711: LUN225L20US
• 07290107016704: LUN225L17US
• 07290107016698: LUN225L15US
• 07290107016681: LUN225L12US
• 07290107014663: LUN225L33US
• 07290107014632: LUN225L08US