Home GUDID 10817929020098 Sonata® Intrauterine Ultrasound Probe
Primary DI 10817929020098
Brand Sonata® Intrauterine Ultrasound Probe
Company GYNESONICS, INC.
Model IUSP-002S
Catalog number IUSP-002S
Device description Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile
Published 2019-05-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use false Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817929020098 Direct Marking GS1 0 10817929020241 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10817929020098 10817929020098 10817929020241 10817929020241
GMDN Terms# Term, Definition table Term Definition Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable A component of an ultrasound-guided intrauterine radio-frequency (RF) ablation system designed to convert electric voltages into an ultrasound beam to produce intrauterine ultrasound images used to monitor/guide electrosurgical procedures. It is typically used as part of a dedicated handpiece and is inserted transcervically into the uterus where it is intended to be manually manoeuvred to steer/focus the ultrasound beam for visualization of uterine pathology (e.g., fibroids). This is a reusable device intended to be sterilized prior to use.
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 40 Degrees Celsius
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 false Serial number true 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 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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850050934233 EndoSound® EVS Probe Endosound, Inc. ITX 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 08800013510112 L8-17H Alpinion Medical Systems Co., Ltd. ITX 2026-05-29 00198953121382 Voluson GE Ultrasound Korea Ltd. ITX 2026-05-28 08800290027266 PA2-9S SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290027419 LA2-9SD SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290028638 CA2-8AD SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029390 EV2-10A SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029420 CV1-8AE SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290027471 EV2-12 SAMSUNG MEDISON CO., LTD. ITX 2026-01-28 08800289975974 R30 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800289976025 R20 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800289979224 EA2-11ARn SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800289979262 CA1-7Sn SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800290027297 PA2-9S SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800290027334 LA2-9Sn SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800290027365 CA3-10An SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08056304455826 MyLabC25 ESAOTE SPA ITX 2025-12-10 08056304455833 MyLabC30 ESAOTE SPA ITX 2025-12-10 08800289979132 cV4 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2025-09-03 08800289981883 cV5 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2025-09-03 08056304455017 MyLabA50 ESAOTE SPA ITX 2025-07-07 08056304455215 MyLabE85 ESAOTE SPA ITX 2025-07-07 08056304455307 MyLabA70 ESAOTE SPA ITX 2025-07-07 08056304455437 MyLabA50 ESAOTE SPA ITX 2025-07-07 08056304455451 MyLabA70 ESAOTE SPA ITX 2025-07-07 08056304455635 MyLabE80 ESAOTE SPA ITX 2025-07-07 08056304455642 MyLabE85 ESAOTE SPA ITX 2025-07-07 08800289970351 cV8 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2025-02-27
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