Synergy MSK Ultrasound 80-02-00023; 80-02-00002; AR-3500-01C

GUDID 07540205000380

Clarius Mobile Health Corp

Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 07540205000380
• NIH Device Record Key: 6bf30e32-33ed-42fe-aeba-427757beb78b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy MSK Ultrasound
• Version Model Number: Synergy Ultrasound Single Charger
• Catalog Number: 80-02-00023; 80-02-00002; AR-3500-01C
• Company DUNS: 202522751
• Company Name: Clarius Mobile Health Corp
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540205000380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172385

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: 2018-12-21
• Device Publish Date: 2018-03-28

On-Brand Devices [Synergy MSK Ultrasound]

• 07540205000410: Synergy Ultrasound Battery
• 07540205000380: Synergy Ultrasound Single Charger