Instrumentation Difra 22186

GUDID B516221860

The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system. With the help of your ENG/VNG system, it performs the calibration of the system and allows you to study eyes movements occurring during the following tests: random saccades, smooth pursuit and optokinetic.

Instrumentation Difra SA

Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system Dynamic visual acuity testing system

• Primary Device ID: B516221860
• NIH Device Record Key: bf39ccf0-049c-4563-bdd0-33b23877157a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra
• Version Model Number: VisioBox II
• Catalog Number: 22186
• Company DUNS: 370173410
• Company Name: Instrumentation Difra SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com
• Phone: 260-804-4041
• Email: dbscherer@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516221860 [Primary]

FDA Product Code

• HOW: Drum, Opticokinetic

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: 2020-05-26
• Device Publish Date: 2020-05-18

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