ClosureRFS

Basic Information

• Brand Name: ClosureRFS
• Primary DI: 10884521058095
• Version / Model: RFS2-6-12
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2024-02-07
• Public Version Status: Update
• Public Device Record Key: 072dcd15-f2ff-430a-8c33-0f544761eca5

Device Description

Endovenous Radiofrequency Stylet,6 Fr/Ch (2.0 mm) x 12 cm

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: Yes
• 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
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62233	Peripheral vascular electrocautery catheter, single-use	A flexible catheter with a distal heating element/electrode intended to be connected to an electrical generator and introduced into the peripheral vasculature to ablate venous tissues, through direct application of heat, as a treatment for venous reflux disease (varicose veins); it is not intended to introduce electrical current into the body. It is a luminal device with a proximal handle with controls (e.g., on/off switch) that is introduced via an introducer assembly (which may be included), and is typically maneuvered under external image guidance [e.g., ultrasound (US)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521058095	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052003	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French
Length	12	Centimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit