FDA.reportPublic FDA data

Skullerz

Primary DI
00720476603023
Brand
Skullerz
Company
Ergodyne
Model
MODI-NEO
Catalog number
60302
Device description
The Skullerz MODI Over-the-Glasses (OTG) Anti-Scratch and Anti-Fog Safety Goggles feature an oversized, wrap-around lens for a wide field of vision and seamless fit over prescription frames. These protective safety goggles feature tough anti-scratch and anti-fog polycarbonate lenses to provide clear vision and protect eyes from flying dust, debris and liquid splashes in tough work environments.The soft gasket lining forms to the wearer’s face for a comfortable, customized fit while sealing out dust, debris and particles. The vented frame allows for airflow and improved anti-fog performance. The neoprene strap is adjustable, comfortably secures on heads, hard hats or caps and is easy to clean when the job gets dirty.
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
00720476603023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00720476603023007204766030237204766030230720476603023

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
00720476603030SkullerzMODI-NEO603032023-08-29
00720476603047SkullerzMODI-RL603042023-08-29
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
04580822704165EYEVANEYEVAN INC.HQY2026-07-10
04580822704172EYEVANEYEVAN INC.HQY2026-07-10
04580822704189EYEVANEYEVAN INC.HQY2026-07-10
04580822704196EYEVANEYEVAN INC.HQY2026-07-10
04580822704660EYEVANEYEVAN INC.HQY2026-07-10
04580822704677EYEVANEYEVAN INC.HQY2026-07-10
04580822704684EYEVANEYEVAN INC.HQY2026-07-10
04580822704691EYEVANEYEVAN INC.HQY2026-07-10
04580822704707EYEVANEYEVAN INC.HQY2026-07-10
04580822705148EYEVANEYEVAN INC.HQY2026-07-10
04580822705155EYEVANEYEVAN INC.HQY2026-07-10
04580822705162EYEVANEYEVAN INC.HQY2026-07-10
04580822705179EYEVANEYEVAN INC.HQY2026-07-10
04580822705186EYEVANEYEVAN INC.HQY2026-07-10
04580822705193EYEVANEYEVAN INC.HQY2026-07-10
04580822705223EYEVANEYEVAN INC.HQY2026-07-10
04580822705230EYEVANEYEVAN INC.HQY2026-07-10
04582669067885E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067892E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067908E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067915E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067922E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068417E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068424E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068455E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068462E5 eyevanEYEVAN INC.HQY2026-07-10
04582669069384EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069391EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069407EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069582EYEVAN7285EYEVAN INC.HQY2026-07-10