Sonata® Intrauterine Ultrasound Probe Return Kit RTN-001

GUDID 10817929020036

GYNESONICS, INC.

Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated

• Primary Device ID: 10817929020036
• NIH Device Record Key: 4db97bf0-ba97-4a47-8284-5d8c1bb3df1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata® Intrauterine Ultrasound Probe Return Kit
• Version Model Number: RTN-001
• Catalog Number: RTN-001
• 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: 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: true

Customer Support Contacts

• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@gynesonics.com
• Phone: 6502163860
• Email: customersupport@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817929020036 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173703

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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

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