FDA.reportPublic FDA data

Regard

Primary DI
00326053117749
Brand
Regard
Company
Resource Optimization & Innovation, L.L.C.
Model
GGLDSPUL-REG
Device description
Goggles Without Ventilation, Universal Size
Published
2020-08-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10326053117746PackageGS1120Not in Commercial Distribution
00326053117749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032605311774610326053117746
00326053117749003260531177493260531177490326053117749

GMDN Terms#

Term, Definition table
TermDefinition
Eye splash shield, single-useA 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 single-use device.

Regulatory Flags#

DUNS number
134472476
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

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