Home GUDID 00860015792013 AVENTIX® PFX System
Primary DI 00860015792013
Brand AVENTIX® PFX System
Company Aventix Medical Inc.
Model PFX01
Catalog number PFX01
Device description The AVENTIX® PFX System includes a generator, controller, and footswitch. The generator sets waveform parameters for the system, and the controller manages arming and disarming and provides system status information. The footswitch enables selective activation of pulsed field energy delivery via the connected NOVOCLEAR™ Device (sold separately).
Published 2026-06-09
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GEI Electrosurgical, Cutting & Coagulation & Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860015792013 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860015792013 00860015792013 860015792013 0860015792013
GMDN Terms# Term, Definition table Term Definition Electrosurgical system An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 119075816 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860015792006 NOVOCLEAR™ Device CLR001 CLR001 2026-06-09
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