ClosureRFG

Basic Information

• Brand Name: ClosureRFG
• Primary DI: 10884521713444
• Version / Model: RFG3
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-11
• Public Version: 10
• Public Version Date: 2023-01-24
• Public Version Status: Update
• Public Device Record Key: 0fafee44-d91c-4d4e-a79e-2155f8b2df5c

Device Description

Radiofrequency Generator

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
35156	Percutaneous radio-frequency ablation system generator	An electrically-powered, noninvasive device designed to generate radio-frequency (RF) electrical current used to create heat via a percutaneously (through the skin) introduced electrode(s) in a precise location, at a controlled temperature, for focal ablation of non-cardiac tissues (e.g., non-cardiac nerves, tumours, precancerous tissue); it may be intended for coagulation however it is not intended for electrosurgical cutting. The generator connects via a delivery cable to an electrosurgical ablation probe/catheter (not included) to transmit the RF electrical current to the operative site; it might additionally be intended to heat an electrode tip (electrocautery).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521713444	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141858	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .5 – 1.06 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, Keep Dry, This side up
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -4 – 158 Degrees Fahrenheit