Synergy MSK Ultrasound Scanner

Basic Information

• Brand Name: Synergy MSK Ultrasound Scanner
• Primary DI: 07540205000373
• Version / Model: Dock Station
• Catalog Number: 80-02-00022; 80-02-00021
• Company Name: Clarius Mobile Health Corp
• Labeler DUNS: 202522751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-28
• Public Version: 4
• Public Version Date: 2020-02-06
• Public Version Status: Update
• Public Device Record Key: 0dbcc5b0-d145-4f69-9cfd-f40b66da485f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07540205000526	GS1
Primary	07540205000373	GS1

Premarket Submissions

Submission Number	Supplement Number
K172385	000