10 MHz probe

GUDID 07290016880076

10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with the FALCON system for noninvasive measurements of blood flow velocities in arteries and veins

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880076
• NIH Device Record Key: 256c2a16-675a-4578-b48d-ecfbf07b332a
• Commercial Distribution Discontinuation: 2020-06-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 10 MHz probe
• Version Model Number: 10 MHz probe
• Company DUNS: 533070236
• Company Name: VIASONIX LTD
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016880076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111416

FDA Product Code

• JOP: Transducer, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-29
• Device Publish Date: 2020-06-19

On-Brand Devices [10 MHz probe ]

• 07290016880076: 10 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returne
• 07290016880410: 10 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects return