Instrumentation Difra

Primary DI
B516221860
Brand
Instrumentation Difra
Company
Instrumentation Difra SA
Model
VisioBox II
Catalog number
22186
Device description
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.
Published
2020-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOWDrum, Opticokinetic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOWDrum, OpticokineticOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B516221860PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dynamic visual acuity testing systemAn assembly of devices used to track changes in visual acuity during head movements primarily to quantify visual acuity loss due to vestibular pathology. The assembly typically includes a three-dimensional (3-D) integrating gyrometer (or equivalent) fastened to the patient's head, a connected personal computer used to track the patient's ability to correctly identify an image according to a specified head movement, a mounted monitor for image viewing, and operating system software. The system helps to identify patients most likely to benefit from vestibular rehabilitation exercises.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
260-804-4041dbscherer@gmail.com

Regulatory Flags#

DUNS number
370173410
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

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Primary DI, Brand, Model table
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B51617473Instrumentation DifraAquaStar 230V 2.0174732018-09-17
B51617481Instrumentation DifraCoolStar 230V 3.0174812018-09-17
B51617485Instrumentation DifraAirStar 2.0174852018-09-17
B51617550Instrumentation DifraAquaStar 115V 2.0175502018-09-17
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B435OKN1TrackerWESTERN SYSTEMS RESEARCH INC.HOW2023-06-27
B51622186Instrumentation DifraInstrumentation Difra SAHOW2018-09-17