Sonata System Software SW-002

GUDID 10817929020340

GYNESONICS, INC.

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• Primary Device ID: 10817929020340
• NIH Device Record Key: dd340bef-aeaa-43c4-b60f-076bd1393ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata System Software
• Version Model Number: SW-002
• Catalog Number: SW-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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817929020340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193516

FDA Product Code

• KNF: Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-15
• Device Publish Date: 2020-10-07

Devices Manufactured by GYNESONICS, INC.

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• 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: 2021-07-15 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