FDA.reportPublic FDA data

ICU Eyewear

Primary DI
00078041048305
Brand
ICU Eyewear
Company
ZOOM EYEWORKS DBA ICU EYEWEAR, INC.
Model
71850108
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
00078041048305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00078041048305000780410483050780410483050078041048305

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
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
06973541158353SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158360SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158377SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158391SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158407SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158414SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158421SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158438SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158445SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158452SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158469SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158476SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158483SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158490SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158506SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158513SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158520SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158537SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158544SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158551SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158568SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158575SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158582SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158599SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158605SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158612SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158629SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
06973541158636SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
16973541158312SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24
16973541158329SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-09-24