EluNIRTM Ridaforolimus Eluting Coronary Stent System

Basic Information

• Brand Name: EluNIRTM Ridaforolimus Eluting Coronary Stent System
• Primary DI: 07290107016711
• Version / Model: LUN225L20US
• Company Name: MEDINOL LTD.
• Labeler DUNS: 600593800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-20
• Public Version: 1
• Public Version Date: 2022-10-28
• Public Version Status: New
• Public Device Record Key: 053c0f13-2f0f-49b5-b10c-599b967a923f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIQ	Coronary Drug-Eluting Stent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
56284	Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated	A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290107016711	GS1

Premarket Submissions

Submission Number	Supplement Number
P170008	038

Device Sizes

Type	Value	Unit	Text
Stent Diameter	2.25	Millimeter
Stent Length	20	Millimeter