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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776429140 Millennium Avalign Technologies, Inc. GEI 2026-09-04 00840113233281 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233304 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233328 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233342 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233366 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233380 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233403 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233427 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233441 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233465 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233489 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233502 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113233526 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237326 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237340 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237593 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237623 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237661 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00840113237692 Bovie ASPEN SURGICAL PRODUCTS, INC. GEI 2026-09-04 00190776428006 Millennium Avalign Technologies, Inc. GEI 2026-08-27 00190776428037 Millennium Avalign Technologies, Inc. GEI 2026-08-27 B4193533010 Maxtown Medical Modern Surgical Instruments LLC GEI 2026-08-27 ESUMARS980010 Sutter Sutter Medizintechnik GmbH GEI 2026-08-27 00190776427436 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427542 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427573 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427672 Millennium Avalign Technologies, Inc. GEI 2026-08-26 00190776427689 Millennium Avalign Technologies, Inc. GEI 2026-08-26 B108890POAMUS00 BTL-890U BTL INDUSTRIES LIMITED GEI 2026-08-26