FRESNEL PRISM AND LENS

Primary DI
08500291040492
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
08500291040492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500291040492085002910404928500291040492

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
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
00850029104414FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29