FDA.reportPublic FDA data

Sonata System Software

Primary DI
10817929020340
Brand
Sonata System Software
Company
Gynesonics, Inc.
Model
SW-002
Catalog number
SW-002
Published
2020-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817929020340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081792902034010817929020340

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound-guided intrauterine radio-frequency ablation system softwareA software program intended for the control of, and data extraction from, an ultrasound-guided intrauterine radio-frequency ablation system. It is intended to collect and display intrauterine ultrasound data in real-time while controlling radio-frequency ablation functions, and may have additional workflow-assistive feature capabilities (e.g., alarms, prompts). It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
650-216-3860customersupport@gynesonics.com

Regulatory Flags#

DUNS number
618493741
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817929020357Sonata® System SoftwareSW-001SW-0012020-02-21
30817929020474Sonata Dispersive ElectrodeDE-0022026-08-25
10817929020241Sonata® Intrauterine Ultrasound ProbeIUSP-002SIUSP-002S2019-05-10
10817929020364Sonata® Dispersive ElectrodeDE-001DE-0012021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableACCY-008ACCY-0082021-07-07
30817929020450Sonata® IUUS Probe Leak TesterACCY-017ACCY-0172023-06-20
10817929020463Sonata® IUUS Probe Connector Protector ACCY-018ACCY-0182022-12-12
10817929020449Sonata® IUUS probe Leak Tester KitACCY-016ACCY-0162023-06-20
10817929020371Sonata® Radiofrequency Ablation HandpieceRFA-002RFA-0022021-07-07
10817929020036Sonata® Intrauterine Ultrasound Probe Return KitRTN-001RTN-0012020-10-07
10817929020166Sonata® Procedure Kit PROKIT-001PROKIT-0012020-10-07
10817929020005Sonata® Case Kit CSKIT-001CSKIT-0012019-05-10
10817929020135Sonata® IUUS Probe Sterile Shipper KitSHPR-001SHPR-0012019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderCYL-001CYL-0012019-05-10
10817929020180Sonata® System Cart ACCY-002ACCY-0022019-05-10
10817929020197Sonata® SMART TabletUSCON-2200USCON-22002019-05-10
10817929020203Sonata® System Radiofrequency GeneratorRFG2-110RFG2-1102019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110SONATA2-1102019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeIUSP-002IUSP-0022019-05-10
10817929020456Sonata® IUUS Probe Leak TesterACCY-017ACCY-0172023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30817929020474Sonata Dispersive ElectrodeGynesonics, Inc.KNF2026-08-25
05708265016280LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
05708265016327LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
05708265016365LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
10817929020364Sonata® Dispersive ElectrodeGynesonics, Inc.KNF2021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableGynesonics, Inc.KNF2021-07-07
14042761086254OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
00810116021666Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021673Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021680Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021642Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
00810116021659Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
10817929020357Sonata® System SoftwareGynesonics, Inc.KNF2020-02-21
10817929020241Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderGynesonics, Inc.KNF2019-05-10
10817929020180Sonata® System Cart Gynesonics, Inc.KNF2019-05-10
10817929020197Sonata® SMART TabletGynesonics, Inc.KNF2019-05-10
10817929020203Sonata® System Radiofrequency GeneratorGynesonics, Inc.KNF2019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc.KNF2019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10381780490128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2019-03-06
10381780490135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2018-09-14
04048551102503n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551102527n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551094631BETTOCCHIKarl Storz GmbH & Co. KGKNF2017-10-20
04048551364864n.a.Karl Storz GmbH & Co. KGKNF2017-05-19
04048551347645n.a.Karl Storz GmbH & Co. KGKNF2016-12-22
10653405035060CONMEDConmed CorporationKNF2016-09-24
10653405035091CONMEDConmed CorporationKNF2016-09-24