Instrumentation Difra

Primary DI
B516220900
Brand
Instrumentation Difra
Company
Instrumentation Difra SA
Model
VIDEOSTAR
Catalog number
22090
Device description
VIDEOSTAR I is a monocular videonystagmoscope device. It transcribes the image of the patient's eye on the computer screen. It helps to asses the reaction of the patient viewing his eye and its nystagmus during testing. The device consists of a goggle that set the camera in front of the patient's eye and allows to occult the patient of the outside, a camera with an infrared lighting and a software running on a computer. The camera is place of the left or the right eye, the other one can either be let free or cover to deny patient's view.
Published
2020-06-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B516220900PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Posturography system platformA device that is a component of a balance/mobility management system equipped with built-in sensors, transducer and/or force plates that register movement of the patient when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output of these movements are measured and recorded to the system computer. It is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies. The patient will stand on this device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
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B51617481Instrumentation DifraCoolStar 230V 3.0174812018-09-17
B51617485Instrumentation DifraAirStar 2.0174852018-09-17
B51617550Instrumentation DifraAquaStar 115V 2.0175502018-09-17
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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860013612900EYE-SYNCNEUROSYNC INC.GWN2025-03-12
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