Diopsys®

Primary DI
10850514007036
Brand
Diopsys®
Company
DIOPSYS, INC.
Model
6020-0001-01
Device description
Disposable Hypoallergenic EEG Electrodes, Case/300
Published
2017-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GWEStimulator, Photic, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWEStimulator, Photic, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101763000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101763000DIOPSYS NOVA VEP VISION TESTING SYSTEMDiopsys, Inc.2011-05-09GWE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850514007036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085051400703610850514007036

GMDN Terms#

Term, Definition table
TermDefinition
Vision electrophysiology analysis systemAn assembly of mains electricity (AC-powered) devices that provides visual stimuli (e.g., patterns of light, images) to a patient to measure, record, and display visual electrophysiologic responses [e.g., electroretinogram (ERG), visual evoked potential (VEP), and electrooculogram (EOG)], typically as an aid in the diagnosis and management of visual disorders involving ocular electrophysiology (EP), e.g., glaucoma. It may involve the use of electrodes placed on the patient's face and eyes, or the use of other devices such as visual stimulation goggles. The system may be used to screen infants and pre-school children for visual disorders without dilation or sedation.

Regulatory Flags#

DUNS number
009972345
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850514007050Diopsys®6020-0002-022017-03-27
20850514007033Diopsys®6020-0001-022017-03-27
00850514007008Diopsys®6020-0010-002017-03-27
00850514007015Diopsys®2320-0020-002017-03-27
00850514007022Diopsys®6020-0011-002017-03-27
00850514007039Diopsys®6020-0001-002017-03-27
00850514007046Diopsys®6020-0002-002017-03-27
00850514007053Diopsys®6020-0002-012017-03-27
00850514007077Diopsys®4028-0005-002017-03-27
00850514007084Diopsys®4028-0010-002017-03-27
00850514007091Diopsys®NOVA 2.192017-03-27
00850514007107Diopsys®2400-0025-002017-05-05

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