FDA.reportPublic FDA data

Skullerz

Primary DI
00720476603078
Brand
Skullerz
Company
Ergodyne
Model
ARKYN-RL
Catalog number
60307
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
00720476603078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00720476603078007204766030787204766030780720476603078

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
00720476603061SkullerzARKYN-RL603062023-08-29
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
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