FRESNEL PRISM AND LENS

Primary DI
00850029104414
Brand
FRESNEL PRISM AND LENS
Company
Fresnel Prism & Lens Company
Model
6300-1
Catalog number
6300-1
Device description
FOIL BAR
Published
2021-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXRFixation, Vision Training, Binocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXRFixation, Vision Training, BinocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850029104414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029104414008500291044148500291044140850029104414

GMDN Terms#

Term, Definition table
TermDefinition
Vision physiology/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, contrast sensitivity, colour perception), and/or eye movement (e.g., pupillary response, saccades, pursuits, fixations) for vision evaluation/screening; it is not intended to measure dimensional/ocular-shape parameters. 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-496-0432info@fresnelprism.com

Regulatory Flags#

DUNS number
789337987
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850029104025MYI OCCLUSION EYE PATCHES0092021-03-29
00850029104032MYI OCCLUSION EYE PATCHES0102021-03-29
00850029104117VISION SCREENING PATCH5110B5110B2021-03-29
00850029104001MYI OCCLUSION EYE PATCHES0082021-03-29
00850029104018MYI OCCLUSION EYE PATCHES0072021-03-29
00850029104049COVERCLUDE OCCLUSION EYE PATCHES0112021-03-29
00850029104056COVERCLUDE OCCLUSION EYE PATCHES0122021-03-29
00850029104124VISION SCREENING PATCHIND5110B2021-03-29
00850029104650FRESNEL PRISM AND LENS6300-B6300-B2023-02-05
00850029104667FRESNEL PRISM AND LENS3005-F3005-F2023-02-05
00850029104674FRESNEL PRISM AND LENS3010-F3010-F2023-02-05
00850029104681FRESNEL PRISM AND LENS3015-F3015-F2023-02-05
00850029104698FRESNEL PRISM AND LENS3020-F3020-F2023-02-05
00850029104704FRESNEL PRISM AND LENS3025-F3025-F2023-02-05
00850029104711FRESNEL PRISM AND LENS3030-F3030-F2023-02-05
00850029104728FRESNEL PRISM AND LENS3035-F3035-F2023-02-05
00850029104735FRESNEL PRISM AND LENS3040-F3040-F2023-02-05
00850029104742FRESNEL PRISM AND LENS3060-F3060-F2023-02-05
00850029104759FRESNEL PRISM AND LENS3080-F3080-F2023-02-05
00850029104766FRESNEL PRISM AND LENS3100-F3100-F2023-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809765430006OTUSĀ® Fixation, Vision Training, BinocularEDENLUX Corp.NXR2025-07-07
B091151330Brock StringGulden Ophthalmics Inc.NXR2023-07-05
00860010599716NeuroEyeCoachNovavision, Inc.NXR2023-07-03
00850029104650FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2023-02-05
08500291040492FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29