Primary Device ID | 10817929020371 |
NIH Device Record Key | 595d6d08-a99c-4adf-a1e8-b83730fcd7ee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sonata® Radiofrequency Ablation Handpiece |
Version Model Number | RFA-002 |
Catalog Number | RFA-002 |
Company DUNS | 618493741 |
Company Name | GYNESONICS, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com | |
Phone | 1-650-216-3860 |
UScustomerservice@gynesonics.com |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10817929020371 [Primary] |
KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-15 |
Device Publish Date | 2021-07-07 |
10817929020449 - Sonata® IUUS probe Leak Tester Kit | 2023-06-28 Invasive medical device leak tester, mechanical. |
10817929020456 - Sonata® IUUS Probe Leak Tester | 2023-06-28 Invasive medical device leak tester, mechanical. |
30817929020368 - Sonata® Dispersive Electrode | 2021-07-15 Electrosurgical return electrode, single-use |
10817929020371 - Sonata® Radiofrequency Ablation Handpiece | 2021-07-15Ultrasound-guided intrauterine electrosurgical handpiece/ electrode |
10817929020371 - Sonata® Radiofrequency Ablation Handpiece | 2021-07-15 Ultrasound-guided intrauterine electrosurgical handpiece/ electrode |
10817929020173 - Sonata® RFA Handpiece Cable, Reusable | 2021-07-15 Electrical-only medical device connection cable, reusable |
10817929020357 - Sonata® System Software | 2021-05-19 Ultrasound-guided radio-frequency ablation system software |
10817929020036 - Sonata® Intrauterine Ultrasound Probe Return Kit | 2020-10-15 |
10817929020166 - Sonata® Procedure Kit | 2020-10-15 Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / elect |
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Goldstein, Ira 2020-08-12 |
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Goldstein, David 2020-08-12 |
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Shanghai Yu'an Electronic Technology Co., Ltd. 2019-05-06 |
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CORTOPASSI FAMILY TRUST 2018-07-05 |
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Hub Pen Company LLC 2017-12-14 |
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Kooapps 2017-03-13 |