Home GUDID 00860015792006 NOVOCLEAR™ Device
Primary DI 00860015792006
Brand NOVOCLEAR™ Device
Company Aventix Medical Inc.
Model CLR001
Catalog number CLR001
Device description The NOVOCLEAR™ Device is a single-use, radiofrequency-based, hand-held device for use with the AVENTIX® PFX System to deliver pulsed field energy to tissue. The NOVOCLEAR™ Device consists of a handle, a dome-like electrode tip, and an electrical connector for connection to the AVENTIX® Generator.
Published 2026-06-09
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true 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 10860015792003 Package GS1 5 In Commercial Distribution 00860015792006 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 10860015792003 10860015792003 00860015792006 00860015792006 860015792006 0860015792006
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 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 true Serial number false Manufacturing date on label false Expiration date on label true 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 00860015792013 AVENTIX® PFX System PFX01 PFX01 2026-06-09
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