Sonalis

GUDID 00852656007014

The Sonalis Ultrasound System is a real time, two dimensional, diagnostic ultrasound system which produces high quality images through user friendly operation. The system currently supports imaging applications for trans-rectal ultrasound imaging.

Best Nomos

General-purpose ultrasound imaging system

• Primary Device ID: 00852656007014
• NIH Device Record Key: 15cc8c7e-8667-41bf-b35a-afdfe99687b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonalis
• Version Model Number: 209876
• Company DUNS: 146920025
• Company Name: Best Nomos
• 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: 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: (412) 312-6700
• Email: info@nomos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852656007014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100204

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-31

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