Sonata® System Radiofrequency Generator RFG2-110

GUDID 10817929020203

Ultrasound-guided intrauterine electrosurgical system generator

GYNESONICS, INC.

Ultrasound-guided intrauterine electrosurgical system generator
Primary Device ID10817929020203
NIH Device Record Keyea87d0f4-c4e0-482d-8421-bd912a80ca2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonata® System Radiofrequency Generator
Version Model NumberRFG2-110
Catalog NumberRFG2-110
Company DUNS618493741
Company NameGYNESONICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-216-3860
Emailcustomersupport@gynesonics.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110817929020203 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-20
Device Publish Date2019-05-10

Devices Manufactured by GYNESONICS, INC.

10817929020449 - Sonata® IUUS probe Leak Tester Kit2023-06-28 Invasive medical device leak tester, mechanical.
10817929020456 - Sonata® IUUS Probe Leak Tester2023-06-28 Invasive medical device leak tester, mechanical.
30817929020368 - Sonata® Dispersive Electrode2021-07-15 Electrosurgical return electrode, single-use
10817929020371 - Sonata® Radiofrequency Ablation Handpiece2021-07-15 Ultrasound-guided intrauterine electrosurgical handpiece/ electrode
10817929020173 - Sonata® RFA Handpiece Cable, Reusable2021-07-15 Electrical-only medical device connection cable, reusable
10817929020357 - Sonata® System Software2021-05-19 Ultrasound-guided radio-frequency ablation system software
10817929020036 - Sonata® Intrauterine Ultrasound Probe Return Kit2020-10-15
10817929020166 - Sonata® Procedure Kit 2020-10-15 Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / elect

Trademark Results [Sonata]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SONATA
SONATA
97852234 not registered Live/Pending
Greenhouse Grown Foods Inc.
2023-03-22
SONATA
SONATA
97558467 not registered Live/Pending
Orthofix US LLC
2022-08-22
SONATA
SONATA
97491975 not registered Live/Pending
SONATA SOFTWARE LIMITED
2022-07-07
SONATA
SONATA
97440953 not registered Live/Pending
Oliveros, Inc
2022-06-02
SONATA
SONATA
97346612 not registered Live/Pending
WENTE BROS.
2022-04-05
SONATA
SONATA
90763809 not registered Live/Pending
Inaugural Financial, Inc.
2021-06-09
SONATA
SONATA
90110226 not registered Live/Pending
Goldstein, Ira
2020-08-12
SONATA
SONATA
90110226 not registered Live/Pending
Goldstein, David
2020-08-12
SONATA
SONATA
88416926 not registered Live/Pending
Shanghai Yu'an Electronic Technology Co., Ltd.
2019-05-06
SONATA
SONATA
88026760 not registered Live/Pending
CORTOPASSI FAMILY TRUST
2018-07-05
SONATA
SONATA
87721225 5519151 Live/Registered
Hub Pen Company LLC
2017-12-14
SONATA
SONATA
87368608 5273154 Live/Registered
Kooapps
2017-03-13

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