FDA.reportPublic FDA data

OZARK TRAIL

Primary DI
00666197777790
Brand
OZARK TRAIL
Company
Eye Ojo Corp.
Model
OT-627908
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00666197777790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00666197777790006661977777906661977777900666197777790

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, reusableA device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
041192266
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00666197671197OZARK TRAILOTPC-YUPL162024-12-09
00666197777806OZARK TRAILOT-6270322024-12-09
00666197825392Hyper ToughHTS-601315A2024-07-03
00666197775345OZARK TRAILYUPL-16PK2024-02-08
00666197776618OZARK TRAILOZFC-OPP2024-02-08
00666197824890Hyper ToughHT13-401-04-062023-12-13
00666197824913Hyper ToughHT13-401-04-012023-12-13
00666197824920Hyper ToughHT13-401-04-022023-12-13
00666197824937Hyper ToughHT13-401-04-032023-12-13
00666197824944Hyper ToughHT13-401-04-042023-12-13
00666197824968Hyper ToughHT13-401-04-052023-12-13
00666197775499OZARK TRAILOZFD-OPP162023-12-01
00666197777752OZARK TRAILOT-6275482023-12-01
00666197777769OZARK TRAILOT-6009832023-12-01
00666197777776OZARK TRAILOT-6011062023-12-01
00666197777783OZARK TRAILOT-6010612023-12-01
00666197824180Hyper ToughHTS-6250592023-06-06
00666197824197Hyper ToughHTS-6904602023-06-06
00666197824203Hyper ToughHTS-617113HG2023-06-06
00666197824227Hyper ToughHTS-3PK2023-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D125720C4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720CR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720T4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
D125720TR4Premium PlusPremium Plus (Dongguan) LimitedHOY2026-06-09
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