Sonata® Radiofrequency Ablation Handpiece RFA-002

GUDID 10817929020371

Ultrasound-guided intrauterine electrosurgical handpiece/ electrode

GYNESONICS, INC.

Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrode

• 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

Customer Support Contacts

• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com
• Phone: 1-650-216-3860
• Email: UScustomerservice@gynesonics.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10817929020371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211535

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

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