Home GUDID 10817929020326 Sonata® Sonography-Guided Transcervical Fibroid Ablation System
Primary DI 10817929020326
Brand Sonata® Sonography-Guided Transcervical Fibroid Ablation System
Company Gynesonics, Inc.
Model SONATA2-110
Catalog number SONATA2-110
Device description Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit.
Published 2019-05-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 10817929020326 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10817929020326 10817929020326
GMDN Terms# Term, Definition table Term Definition Ultrasound-guided intrauterine electrosurgical system An assembly of devices that uses electrical energy in the radio-frequency (RF) band designed to develop heat directly within soft-tissue cells for transcervical and intrauterine ablation of uterine fibroids, and uses ultrasound to target the RF delivery. It consists of a electrosurgical generator; a software-controlled ultrasound system; a vaginal ultrasound transducer; a handpiece with an intrauterine ultrasound transducer and monopolar electrosurgical electrode; and a return electrode. It also typically includes associated cables, a foot-switch, and an ultrasound image recording device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 45 Degrees Celsius
Regulatory Flags# DUNS number 618493741 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 10817929020357 Sonata® System Software SW-001 SW-001 2020-02-21 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 10817929020340 Sonata System Software SW-002 SW-002 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 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 30817929020368 Sonata® Dispersive Electrode DE-001 DE-001 2021-07-07
Other Devices Sharing Product Codes# 
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