Sonata® IUUS Probe Connector Protector ACCY-018

GUDID 10817929020463

Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures.

Gynesonics, Inc.

Non-submersible device disinfection chamber

• Primary Device ID: 10817929020463
• NIH Device Record Key: 342f3116-9c15-4d2d-9505-8a4f58be7bb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata® IUUS Probe Connector Protector
• Version Model Number: ACCY-018
• Catalog Number: ACCY-018
• 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: true
• 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: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 650-216-3860
• Email: UScustomerservice@gynesonics.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817929020463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222304

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-05-26
• Device Publish Date: 2022-12-12

Devices Manufactured by Gynesonics, Inc.

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• 10817929020463 - Sonata® IUUS Probe Connector Protector: 2025-05-26 Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the
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• 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