FDA.reportPublic FDA data

VISION SCREENING PATCH

Primary DI
00850029104124
Brand
VISION SCREENING PATCH
Company
Fresnel Prism & Lens Company
Model
IND5110B
Device description
PATCH, VISION SCREENING, INDIVIDUAL
Published
2021-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850029104124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850029104124008500291041248500291041240850029104124

GMDN Terms#

Term, Definition table
TermDefinition
Eye patchA device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.

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
Lot or batch
true
Expiration date on label
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
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
00850029104773FRESNEL PRISM AND LENS3120-F3120-F2023-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770535583Bausch + LombBausch & Lomb IncorporatedHOY2026-04-30
16931918105420AllesetGRI Medical & Electronic Technology Co., Ltd.HOY2026-04-10
10620974004285BetterShieldSouthmedic IncorporatedHOY2025-12-19
D2481009320"""Heidi"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009330"""Ella"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
D2481009350"""Lucy"" Protective Eyewear "HAGER WORLDWIDE, INC.HOY2025-10-22
10827989003504Health Care Logistics, Inc®Health Care Logistics, Inc.HOY2025-01-08
TQ26126151971Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.HOY2024-12-09
10889483047910SunMed LLCSUNMED, LLCHOY2024-11-11
10887482176815BovieASPEN SURGICAL PRODUCTS, INC.HOY2024-08-26
00194613017101MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613028190MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-08-15
00194613002770MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2024-04-25
00630094055114Bioseal Inc.BIOSEALHOY2024-01-29
00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
00630094055145Bioseal Inc.BIOSEALHOY2024-01-29
00630094055190Bioseal Inc.BIOSEALHOY2024-01-29
00630094404721Bioseal Inc.BIOSEALHOY2024-01-29
00630094540160Bioseal Inc.BIOSEALHOY2024-01-29
00630094540337Bioseal Inc.BIOSEALHOY2024-01-29
00630094540474Bioseal Inc.BIOSEALHOY2024-01-29
00630094551913Bioseal Inc.BIOSEALHOY2024-01-29
00630094551937Bioseal Inc.BIOSEALHOY2024-01-29
00630094053707Bioseal Inc.BIOSEALHOY2024-01-26
00630094053738Bioseal Inc.BIOSEALHOY2024-01-26
00630094053905Bioseal Inc.BIOSEALHOY2024-01-26
00630094540016Bioseal Inc.BIOSEALHOY2024-01-26
08052276029638Eye Shield AKTIVE SRLHOY2024-01-15
00630094183411Bioseal Inc.BIOSEALHOY2023-10-05
00630094183459Bioseal Inc.BIOSEALHOY2023-10-05