Home GUDID 10817929020166 Sonata® Procedure Kit
Primary DI 10817929020166
Brand Sonata® Procedure Kit
Company Gynesonics, Inc.
Model PROKIT-001
Catalog number PROKIT-001
Device description Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable.
Published 2020-10-07
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10817929020166 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10817929020166 10817929020166
GMDN Terms# Term, Definition table Term Definition Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use 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 40 Degrees Celsius
Regulatory Flags# DUNS number 618493741 Device count 1 Kit true Lot or batch true Expiration 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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05708265016280 LiNA Gold Loop™ LiNA Medical AG KNF 2026-04-02 05708265016327 LiNA Gold Loop™ LiNA Medical AG KNF 2026-04-02 05708265016365 LiNA Gold Loop™ LiNA Medical AG KNF 2026-04-02 10817929020364 Sonata® Dispersive Electrode Gynesonics, Inc. KNF 2021-07-07 30817929020177 Sonata® RFA Handpiece Cable, Reusable Gynesonics, Inc. KNF 2021-07-07 14042761086254 Olympus OLYMPUS Winter & Ibe GmbH KNF 2020-07-31 14042761086278 Olympus OLYMPUS Winter & Ibe GmbH KNF 2020-07-31 00810116021666 Dornier MedTech DORNIER MEDTECH AMERICA, INC. KNF 2020-06-19 00810116021673 Dornier MedTech DORNIER MEDTECH AMERICA, INC. KNF 2020-06-19 00810116021680 Dornier MedTech DORNIER MEDTECH AMERICA, INC. KNF 2020-06-19 00810116021642 Dornier MedTech DORNIER MEDTECH AMERICA, INC. KNF 2020-06-18 00810116021659 Dornier MedTech DORNIER MEDTECH AMERICA, INC. KNF 2020-06-18 10817929020241 Sonata® Intrauterine Ultrasound Probe Gynesonics, Inc. KNF 2019-05-10 10817929020142 Sonata® IUUS Probe Soaking Cylinder Gynesonics, Inc. KNF 2019-05-10 10817929020180 Sonata® System Cart Gynesonics, Inc. KNF 2019-05-10 10817929020197 Sonata® SMART Tablet Gynesonics, Inc. KNF 2019-05-10 10817929020203 Sonata® System Radiofrequency Generator Gynesonics, Inc. KNF 2019-05-10 10817929020326 Sonata® Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc. KNF 2019-05-10 30817929020092 Sonata® Intrauterine Ultrasound Probe Gynesonics, Inc. KNF 2019-05-10 10381780490128 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION KNF 2019-03-06 10381780490135 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION KNF 2018-09-14 04048551102503 n.a. Karl Storz GmbH & Co. KG KNF 2018-07-21 04048551102527 n.a. Karl Storz GmbH & Co. KG KNF 2018-07-21 04048551094631 BETTOCCHI Karl Storz GmbH & Co. KG KNF 2017-10-20 04048551364864 n.a. Karl Storz GmbH & Co. KG KNF 2017-05-19 04048551347645 n.a. Karl Storz GmbH & Co. KG KNF 2016-12-22 10653405035060 CONMED Conmed Corporation KNF 2016-09-24 10653405035091 CONMED Conmed Corporation KNF 2016-09-24 00817428020721 Modulap ATC TECHNOLOGIES, INC. KNF 2016-09-24 04046963682262 AESCULAP Aesculap AG KNF 2016-09-24
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