8 MHz probe

GUDID 07290016880069

8 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals that intended to be used in combination with

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880069
• NIH Device Record Key: d02ae0dc-a3db-4bf4-8827-703ba05d98b8
• Commercial Distribution Discontinuation: 2017-12-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 8 MHz probe
• Version Model Number: 8 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	07290016880069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170859

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: 2017-12-19

On-Brand Devices [8 MHz probe ]

• 07290016880069: 8 MHz probe is an ultrasonic transducer which generate acoustic signals and also detect returned
• 07290016880403: 8 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returne