FDA.reportPublic FDA data

ICU Eyewear

Primary DI
00078041220572
Brand
ICU Eyewear
Company
ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
Model
60150001X
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00078041220572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078041220572000780412205720780412205720078041220572

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
001952241
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00078041002383ICU Eyewear10580205ZX2022-12-01
00078041003120ICU Eyewear201501012022-12-01
00078041003137ICU Eyewear201501022022-12-01
00078041003144ICU Eyewear201501032022-12-01
00078041003151ICU Eyewear201501042022-12-01
00078041003168ICU Eyewear201501062022-12-01
00078041003175ICU Eyewear201501072022-12-01
00078041003182ICU Eyewear201501082022-12-01
00078041003199ICU Eyewear201501052022-12-01
00078041013884ICU Eyewear503092082022-12-01
00078041014010ICU Eyewear702200082022-12-01
00078041036722ICU Eyewear702200012022-12-01
00078041036739ICU Eyewear702200022022-12-01
00078041036746ICU Eyewear702200032022-12-01
00078041036753ICU Eyewear702200042022-12-01
00078041036777ICU Eyewear702200062022-12-01
00078041048251ICU Eyewear718501022022-12-01
00078041048268ICU Eyewear718501032022-12-01
00078041048275ICU Eyewear718501042022-12-01
00078041048299ICU Eyewear718501062022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04582647307972MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307989MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647307996MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308146MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308153MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308160MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308313MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308320MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308375MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308382MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308399MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308405MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308412MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308429MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308436MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308443MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308450MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308467MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308559MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308566MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308573MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308641MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
04582647308658MASUNAGA MOCMASUNAGA OPTICAL MFG.CO.,LTD.HQY2026-07-30
08800348920907Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920914Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920921Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920938Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920945Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920952Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22
08800348920969Blue ElephantBlue Elephant Co.,Ltd.HQY2026-07-22