Sonata® IUUS Probe Soaking Cylinder CYL-001

GUDID 10817929020142

General laboratory container, reusable

GYNESONICS, INC.

General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable General laboratory container, reusable

• Primary Device ID: 10817929020142
• NIH Device Record Key: e7c4baa1-a346-40ce-b1b2-e12b21bf68ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata® IUUS Probe Soaking Cylinder
• Version Model Number: CYL-001
• Catalog Number: CYL-001
• Company DUNS: 618493741
• Company Name: GYNESONICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
• 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
• Phone: 650-216-3860
• Email: customersupport@gynesonics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817929020142 [Primary]

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2019-05-20
• Device Publish Date: 2019-05-10

Devices Manufactured by GYNESONICS, INC.

• 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: 2021-07-15 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