FDA.reportPublic FDA data

Skullerz

Primary DI
00720476603047
Brand
Skullerz
Company
Ergodyne
Model
MODI-RL
Catalog number
60304
Device description
The Skullerz MODI OTG Safety Goggles Replacement Lens is designed to securely attach to Skullerz MODI Safety Goggles. This anti-scratch and anti-fog lens is available in both clear and smoke and easily installs with the MODI side latch 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
00720476603047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00720476603047007204766030477204766030470720476603047

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
00720476603054SkullerzMODI-RL603052023-08-29
00720476603061SkullerzARKYN-RL603062023-08-29
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
16973541157797SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158227SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158234SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158241SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158258SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158265SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158272SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158289SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158296SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
26973541158302SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-08-27
00754317216479Ernest HemingwayNew York EyeHQY2026-08-17
00754317216486Ernest HemingwayNew York EyeHQY2026-08-17
00754317218022Ernest HemingwayNew York EyeHQY2026-08-17
00754317218039Ernest HemingwayNew York EyeHQY2026-08-17
00754317228151Valerie SpencerNew York EyeHQY2026-08-17
00754317228618Marc HunterNew York EyeHQY2026-08-17
00754317228625Marc HunterNew York EyeHQY2026-08-17
00754317228632Marc HunterNew York EyeHQY2026-08-17
00754317228649Marc HunterNew York EyeHQY2026-08-17
00754317228656Valerie SpencerNew York EyeHQY2026-08-17
00754317228663Valerie SpencerNew York EyeHQY2026-08-17
00754317228670Valerie SpencerNew York EyeHQY2026-08-17
00754317228687Valerie SpencerNew York EyeHQY2026-08-17
00754317228694Valerie SpencerNew York EyeHQY2026-08-17
00754317228731Ernest HemingwayNew York EyeHQY2026-08-17
00754317228748Ernest HemingwayNew York EyeHQY2026-08-17
08800348923403Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923410Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923427Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14
08800348923441Blue ElephantBlue Elephant Co.,Ltd.HQY2026-08-14