Home GUDID 30817929020450 Sonata® IUUS Probe Leak Tester
Primary DI 30817929020450
Brand Sonata® IUUS Probe Leak Tester
Company Gynesonics, Inc.
Model ACCY-017
Catalog number ACCY-017
Device description Invasive medical device leak tester, mechanical.
Published 2023-06-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true Product Codes# Code, Name table Code Name FCY Bulb, Inflation, For Endoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817929020456 Direct Marking GS1 0 30817929020450 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10817929020456 10817929020456 30817929020450 30817929020450
GMDN Terms# Term, Definition table Term Definition Invasive medical device leak tester, mechanical A hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 60 Degrees Celsius
Regulatory Flags# DUNS number 618493741 Device count 1 Premarket exempt true Lot or batch 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 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 30817929020368 Sonata® Dispersive Electrode DE-001 DE-001 2021-07-07
Other Devices Sharing Product Codes# 
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