Neurolign Dx NOTC

Primary DI
B818NOTC0
Brand
Neurolign Dx NOTC
Company
Spryson America, Inc.
Model
Dx NOTC
Catalog number
Dx NOTC
Device description
Nystagmograph
Published
2020-07-01
Public version status
Update
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
GWNNystagmograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWNNystagmographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B290NOTC0PreviousHIBCC0
B818NOTC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vision/eye movement analysis systemAn electronic unit or device assembly intended to measure, record, and display a range of parameters associated with vision electrophysiology [e.g., electroretinogram (ERG), visual evoked potential (VEP), electrooculogram (EOG)], and/or psychophysical vision (e.g., visual acuity/fields, refractive error, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening. Features may include visual stimuli (e.g., patterns of light/images) and/or devices for sensing/tracking (e.g., bioelectric amplifiers, video or infrared cameras). It is intended to be used by a healthcare professional in a clinical setting.

Regulatory Flags#

DUNS number
119206320
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
false
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
B818DX100Neurolign Dx100Dx100Dx1002020-07-01
B818SVNG0Neurolign Dx SVNGDx SVNGDx SVNG2020-07-01

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