EyeBOX SNAP

Primary DI
00810051680027
Brand
EyeBOX SNAP
Company
Oculogica Inc.
Model
DMR-0005
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEABrain Injury Adjunctive Interpretive Oculomotor Assessment AidNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810051680027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051680027008100516800278100516800270810051680027

GMDN Terms#

Term, Definition table
TermDefinition
Eye-tracking neurological/brain injury assessment deviceAn electrically-powered unit intended to measure and analyse eye movement to assist in the diagnosis/assessment of a neurological disorder [e.g., autism spectrum disorder (ASD), attention-deficit hyperactivity disorder (ADHD), dementia] or potential traumatic brain injury (e.g., concussion). It includes visual stimuli (e.g., videos) and devices for sensing/tracking eye movement (e.g., infrared cameras), dedicated software for analysing results and providing management guidelines, and a user interface for viewing/input. It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Regulatory Flags#

DUNS number
078866200
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810051680010EyeBOXDMR-00042026-05-19
00810051680003EyeBOXOCL 02.52021-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810051680010EyeBOXOculogica Inc.QEA2026-05-19
00860013612900EYE-SYNCNEUROSYNC INC.QEA2025-03-12
00810051680003EyeBOXOculogica Inc.QEA2021-09-21