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
Primary Device IDB516221860
NIH Device Record Keybf39ccf0-049c-4563-bdd0-33b23877157a
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstrumentation Difra
Version Model NumberVisioBox II
Catalog Number22186
Company DUNS370173410
Company NameInstrumentation Difra SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com
Phone260-804-4041
Emaildbscherer@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB516221860 [Primary]

FDA Product Code

HOWDrum, Opticokinetic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-26
Device Publish Date2020-05-18

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