Synergy MSK Ultrasound Scanner 80-02-00022; 80-02-00021

GUDID 07540205000526

Clarius Mobile Health Corp

Noninvasive device battery charger

• Primary Device ID: 07540205000526
• NIH Device Record Key: 0dbcc5b0-d145-4f69-9cfd-f40b66da485f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy MSK Ultrasound Scanner
• Version Model Number: Dock Station
• Catalog Number: 80-02-00022; 80-02-00021
• 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	07540205000373 [Primary]
GS1	07540205000526 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172385

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2020-02-06
• Device Publish Date: 2017-09-28

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