FDA.reportPublic FDA data

Opti-Gard

Primary DI
10850017419077
Brand
Opti-Gard
Company
DUPACO, INC.
Model
D28400
Catalog number
D28400
Device description
LASER OPTI-GARD LARGE 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
10850017419077PrimaryGS10
00850017419070Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001741907710850017419077
00850017419070008500174190708500174190700850017419070

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding goggles/spectaclesA personal protective device in the form of eyewear/glasses with clear lenses intended to be used to shield the eyes of healthcare staff from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. It is designed as uncorrected (non-prescription) or corrected (prescription) goggles or spectacles with lenses and side shields made of radiation-protecting materials (e.g., glass, plastic). The lenses and side shields offer additional physical barrier protection from liquid radioactive materials.

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
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850017419039Opti-GardD28200CED28200CE2020-10-30
10850017419046Opti-GardD28300CED28300CE2020-10-30
10850017419053Opti-GardD28300FD28300F2020-10-30
10850017419060Opti-GardD28310D283102020-10-30
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

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Primary DI, Brand, Company table
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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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