Sonata® Radiofrequency Ablation Handpiece RFA-002

GUDID 10817929020371

Ultrasound-guided intrauterine electrosurgical handpiece/ electrode

GYNESONICS, INC.

Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode
Primary Device ID10817929020371
NIH Device Record Key595d6d08-a99c-4adf-a1e8-b83730fcd7ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonata® Radiofrequency Ablation Handpiece
Version Model NumberRFA-002
Catalog NumberRFA-002
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com
Phone1-650-216-3860
EmailUScustomerservice@gynesonics.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110817929020371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-15
Device Publish Date2021-07-07

Devices Manufactured by GYNESONICS, INC.

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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 Handpiece2021-07-15Ultrasound-guided intrauterine electrosurgical handpiece/ electrode
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

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Company
Trademark
Application Date
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2022-06-02
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2022-04-05
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2021-06-09
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2020-08-12
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2020-08-12
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88416926 not registered Live/Pending
Shanghai Yu'an Electronic Technology Co., Ltd.
2019-05-06
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88026760 not registered Live/Pending
CORTOPASSI FAMILY TRUST
2018-07-05
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87721225 5519151 Live/Registered
Hub Pen Company LLC
2017-12-14
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2017-03-13

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