Sonata® Intrauterine Ultrasound Probe IUSP-002S

GUDID 10817929020098

Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile

GYNESONICS, INC.

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable

• Primary Device ID: 10817929020098
• NIH Device Record Key: aab28921-ca11-4a18-9098-96c07adeff55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonata® Intrauterine Ultrasound Probe
• Version Model Number: IUSP-002S
• Catalog Number: IUSP-002S
• 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: false
• Serial Number: true
• 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: 650-216-3860
• Email: customersupport@gynesonics.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817929020098 [Direct Marking]
GS1	10817929020241 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-16
• Device Publish Date: 2019-05-10

On-Brand Devices [Sonata® Intrauterine Ultrasound Probe]

• 30817929020092: Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transduc
• 10817929020098: Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transduc