FDA.reportPublic FDA data

Instrumentation Difra

Primary DI
B51622092
Brand
Instrumentation Difra
Company
Instrumentation Difra SA
Model
VIDEOSTAR II
Catalog number
22092
Device description
The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to visualize eye reaction of the patient and record digital video.Freefield videonystagmoscope digital USB2
Published
2018-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJJLens, Fresnel, Flexible, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJJLens, Fresnel, Flexible, DiagnosticOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B51622092PrimaryHIBCC0

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.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B516327270Instrumentation Difra SANysStar PRO327272026-03-09
B516325950Instrumentation Difra SAHeadStar V3.0325952025-03-12
B516326290Instrumentation Difra SAHeadStar V3.0326292025-03-12
B516326380Instrumentation Difra SAHeadStar V3.0326382025-03-12
B516308640Instrumentation Difra SANysStar II 308642024-08-19
B516320980Instrumentation Difra SAHeadStar V2.0320982024-01-31
B516311790Instrumentation Difra SANysStar II with VOR 311792022-11-02
B516310120Instrumentation Difra SAAirStar 230V310122022-09-28
B516310130Instrumentation Difra SAAirStar 115V310132022-09-28
B516223150Instrumentation DifraIdeas III223152021-06-28
B516174730Instrumentation DifraAquaStar 230V 2.0174732020-05-18
B516174810Instrumentation DifraCoolStar 230V 3.0174812020-05-18
B516174850Instrumentation DifraAirStar 2.0174852020-05-18
B516175500Instrumentation DifraAquaStar 115V 2.0175502020-05-18
B516175530Instrumentation DifraCoolStar 115V 3.0175532020-05-18
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
B51617553Instrumentation DifraCoolStar 115V 3.0175532018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B51622090Instrumentation DifraInstrumentation Difra SAHJJ2018-09-17