Tracker

Primary DI
B435OKN1
Brand
Tracker
Company
WESTERN SYSTEMS RESEARCH INC.
Model
CUBE-OKN
Published
2023-06-27
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
B435OKN1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nystagmus inducing optokinetic drumA drum-like ophthalmic device covered with alternating white and dark stripes or pictures. The device is rotated in front of the patient's eyes and is intended to elicit nystagmus (involuntary rapid movement of the eyeball). This is used to diagnose the patient and is particularly useful for babies and children who cannot communicate, e.g., if nystagmus cannot be induced, this suggests that the child suffers from impaired vision or blindness.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608365466
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B435ENGEV2000ENGplus™EV20002023-08-09
B435MT07MotionTrakMT072023-06-27
B435EV2000VAT®EV20002017-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B516221860Instrumentation DifraInstrumentation Difra SAHOW2020-05-18
B51622186Instrumentation DifraInstrumentation Difra SAHOW2018-09-17