EverFlex

Basic Information

• Brand Name: EverFlex
• Primary DI: 00821684034286
• Version / Model: PRB35-07-060-120
• Company Name: Covidien LP
• Labeler DUNS: 968903703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-22
• Public Version: 7
• Public Version Date: 2024-01-08
• Public Version Status: Update
• Public Device Record Key: 1d7ede68-cb3b-4f77-8e90-9834699157ee

Device Description

Self-Expanding Peripheral Stent System

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIP	STENT, SUPERFICIAL FEMORAL ARTERY	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47932	Peripheral artery stent, bare-metal	A non-bioabsorbable tubular device intended to be implanted in a peripheral artery (excludes aorta, coronary, and intracranial arteries) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease, or following the recanalization of a total occlusion. It may additionally be intended to be implanted in an obstructed biliary duct; it is not dedicated to carotid artery implantation. The stent is made entirely of metal [e.g., nickel-titanium alloy (Nitinol) mesh structure] and is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821684034286	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P110023	004

Device Sizes

Type	Value	Unit	Text
Length	60	Millimeter
Outer Diameter	7	Millimeter
Outer Diameter	2	Millimeter
Catheter Gauge	6	French
Device Size Text, specify			Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,5.5 to 6.5,Millimeter;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry