ClosureRFS™

Basic Information

• Brand Name: ClosureRFS™
• Primary DI: 00643169862999
• Version / Model: RFS2-6-12
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-14
• Public Version: 4
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: 2461f9e3-df57-455f-8f6a-40ab350536d3

Device Description

STYLET RFS2-6-12 CLOSURE FAST V02

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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	00643169862999	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052003	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Working Length 12 CM
Outer Diameter	2.0	Millimeter
Catheter Gauge	6.0	French

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius