Instrumentation Difra 22315

GUDID B516223150

The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro-oculography (EOG). In this method, skinmounted electrodes measure changes in potentials across the eyeball due to movement of the eye in its socket. The corneal retinal potential is the source of the measured voltage. Those movements are recorded and transmitted to a computer. The eye movement is analyzed by the software.Ideas III is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests). Ideas III is able to record horizontal and vertical movements simultaneously on both eyes or on one eye only.

Instrumentation Difra SA

Electronystagmograph

• Primary Device ID: B516223150
• NIH Device Record Key: 67fba97f-29f2-40ef-a2db-3bbe7607a71e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra
• Version Model Number: Ideas III
• Catalog Number: 22315
• Company DUNS: 370173410
• Company Name: Instrumentation Difra SA
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516223150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070670

FDA Product Code

• GWN: Nystagmograph

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: 2021-07-06
• Device Publish Date: 2021-06-28

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