FDA.reportPublic FDA data

Skullerz

Primary DI
00720476603061
Brand
Skullerz
Company
Ergodyne
Model
ARKYN-RL
Catalog number
60306
Device description
The Skullerz ARKYN Safety Goggles Replacement Lens is designed to securely attach to Skullerz ARKYN Safety Goggles. This anti-scratch and anti-fog lens is available in both clear and smoke and easily installs with the ARKYN turn-to-lock buckle system.
Published
2023-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00720476603061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00720476603061007204766030617204766030610720476603061

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108665142
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00720476570059SkullerzBALDR-AFAS570052023-07-13
00720476570356SkullerzBALDR-AFAS570352023-07-13
00720476570851SkullerzBALDR-AFAS570852023-07-13
00720476603009SkullerzMODI-FAB603002023-08-29
00720476603016SkullerzMODI-FAB603012023-08-29
00720476603023SkullerzMODI-NEO603022023-08-29
00720476603030SkullerzMODI-NEO603032023-08-29
00720476603047SkullerzMODI-RL603042023-08-29
00720476603054SkullerzMODI-RL603052023-08-29
00720476603078SkullerzARKYN-RL603072023-08-29
00720476603108SkullerzARKYN-NEO603102023-08-29
00720476603115SkullerzARKYN-NEO603112023-08-29
00720476571339SkullerzBALDR-AF571332023-08-28
00720476571506SkullerzBALDR571502023-08-28
00720476573203SkullerzBALDR-AF573202023-08-28
00720476573302SkullerzBALDR573302023-08-28
00720476573319SkullerzBALDR-PZ573312023-08-28
00720476573333SkullerzBALDR-AF573332023-08-28
00720476574033SkullerzBALDR574032023-08-28
00720476574309SkullerzBALDR574302023-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209038196FielmannFielmann Group AGHQY2026-07-06
04066209038202FielmannFielmann Group AGHQY2026-07-06
04066209038219FielmannFielmann Group AGHQY2026-07-06
04066209053885FielmannFielmann Group AGHQY2026-07-06
04066209060180FielmannFielmann Group AGHQY2026-07-06
04066209060197FielmannFielmann Group AGHQY2026-07-06
04066209060203FielmannFielmann Group AGHQY2026-07-06
04066209060265FielmannFielmann Group AGHQY2026-07-06
04066209060289FielmannFielmann Group AGHQY2026-07-06
04066209060388FielmannFielmann Group AGHQY2026-07-06
04066209060470FielmannFielmann Group AGHQY2026-07-06
04066209060845FielmannFielmann Group AGHQY2026-07-06
04066209061132FielmannFielmann Group AGHQY2026-07-06
04066209063570FielmannFielmann Group AGHQY2026-07-06
04066209064416FielmannFielmann Group AGHQY2026-07-06
04066209064430FielmannFielmann Group AGHQY2026-07-06
04066209064874FielmannFielmann Group AGHQY2026-07-06
06973541158131SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
16973541158138SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
06974213566148MalibuWENZHOU TIDE-OPTICAL CO.,LTDHQY2026-07-03
08800348920280Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920297Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920303Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920310Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920327Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920334Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920341Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920358Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920365Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920372Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25