FDA.reportPublic FDA data

ICU Eyewear

Primary DI
00078041013884
Brand
ICU Eyewear
Company
ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
Model
50309208
Published
2022-12-01
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
HOISpectacle, magnifying
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOISpectacle, MagnifyingOphthalmic1
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00078041013884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078041013884000780410138840780410138840078041013884

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectacle lensAn ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).

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
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
00078041048305ICU Eyewear718501082022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973541158315SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158322SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158339SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
00676190876697Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876734Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00676190876772Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539937Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
00881814540018Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
08908016666505SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666529SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666536SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08908016666635SunglassPRAMARA PROMOTIONS LIMITEDHQY2026-05-29
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13