Home GUDID 10817929020357 Sonata® System Software
Primary DI 10817929020357
Brand Sonata® System Software
Company Gynesonics, Inc.
Model SW-001
Catalog number SW-001
Device description Ultrasound-guided radio-frequency ablation system software
Published 2020-02-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic IYO System, Imaging, Pulsed Echo, Ultrasonic KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2 KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817929020357 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10817929020357 10817929020357
GMDN Terms# Term, Definition table Term Definition Ultrasound-guided intrauterine radio-frequency ablation system software A software program intended for the control of, and data extraction from, an ultrasound-guided intrauterine radio-frequency ablation system. It is intended to collect and display intrauterine ultrasound data in real-time while controlling radio-frequency ablation functions, and may have additional workflow-assistive feature capabilities (e.g., alarms, prompts). It does not incorporate adaptive/dynamic machine learning (ML) models.
Regulatory Flags# DUNS number 618493741 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 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 10817929020340 Sonata System Software SW-002 SW-002 2020-10-07 30817929020474 Sonata Dispersive Electrode DE-002 2026-08-25 10817929020241 Sonata® Intrauterine Ultrasound Probe IUSP-002S IUSP-002S 2019-05-10 10817929020364 Sonata® Dispersive Electrode DE-001 DE-001 2021-07-07 30817929020177 Sonata® RFA Handpiece Cable, Reusable ACCY-008 ACCY-008 2021-07-07 30817929020450 Sonata® IUUS Probe Leak Tester ACCY-017 ACCY-017 2023-06-20 10817929020463 Sonata® IUUS Probe Connector Protector ACCY-018 ACCY-018 2022-12-12 10817929020449 Sonata® IUUS probe Leak Tester Kit ACCY-016 ACCY-016 2023-06-20 10817929020371 Sonata® Radiofrequency Ablation Handpiece RFA-002 RFA-002 2021-07-07 10817929020036 Sonata® Intrauterine Ultrasound Probe Return Kit RTN-001 RTN-001 2020-10-07 10817929020166 Sonata® Procedure Kit PROKIT-001 PROKIT-001 2020-10-07 10817929020005 Sonata® Case Kit CSKIT-001 CSKIT-001 2019-05-10 10817929020135 Sonata® IUUS Probe Sterile Shipper Kit SHPR-001 SHPR-001 2019-05-10 10817929020142 Sonata® IUUS Probe Soaking Cylinder CYL-001 CYL-001 2019-05-10 10817929020180 Sonata® System Cart ACCY-002 ACCY-002 2019-05-10 10817929020197 Sonata® SMART Tablet USCON-2200 USCON-2200 2019-05-10 10817929020203 Sonata® System Radiofrequency Generator RFG2-110 RFG2-110 2019-05-10 10817929020326 Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110 SONATA2-110 2019-05-10 30817929020092 Sonata® Intrauterine Ultrasound Probe IUSP-002 IUSP-002 2019-05-10 10817929020456 Sonata® IUUS Probe Leak Tester ACCY-017 ACCY-017 2023-06-20
Other Devices Sharing Product Codes# 
gynesonics.com