FDA.reportPublic FDA data

Opti-Gard

Primary DI
10850017419039
Brand
Opti-Gard
Company
DUPACO, INC.
Model
D28200CE
Catalog number
D28200CE
Device description
Opti-Gard SMALL CE NON-STERILE PACK
Published
2020-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
IWSShield, eye, radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1
IWSShield, Eye, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850017419039PrimaryGS10
00850017419032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001741903910850017419039
00850017419032008500174190328500174190320850017419032

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature40 Degrees Fahrenheit80 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(760)758-4550dly@dupacoinc.com

Regulatory Flags#

DUNS number
093616555
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850017419046Opti-GardD28300CED28300CE2020-10-30
10850017419053Opti-GardD28300FD28300F2020-10-30
10850017419060Opti-GardD28310D283102020-10-30
10850017419077Opti-GardD28400D284002020-10-30
10850017419084Opti-GardD29400D294002020-10-30
10850017419107ProneViewD28507CED28507CE2020-10-30
10850017419114ProneViewD28505CED28505CE2020-10-30
10850017419121ProneViewD28503CED28503CE2020-10-30
10850017419138ProneViewD28600D286002020-10-30
10850017419145ProneViewD28630D286302020-10-30
10850017419152ProneViewD28701D287012020-10-30
10850017419169ProneViewD28621D286212020-10-30
10850017419176ProneViewD28655D286552020-10-30
10850017419183ProneViewD28707D287072020-10-30
10850017419190ProneViewD28706D287062020-10-30
10850017419312ProneViewD29720D297202020-10-30
10850017419329Opti-GardD28200CE-BrazilD28200CE-Brazil2020-10-30
10850017419336Opti-GardD28300CE-BrazilD28300CE-Brazil2020-10-30
20850017419128ProneViewD28503CE-60D28503CE-602020-10-30
00850017419346ProneViewD28705CED28705CE2020-10-30

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
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00630094055138Bioseal Inc.BIOSEALHOY2024-01-29
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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