FDA.reportPublic FDA data

Etnia Eyewear Culture

Primary DI
18435685057961
Brand
Etnia Eyewear Culture
Company
Etnia Barcelona LLC
Model
5 GRIMM 43S 30 FU
Device description
Sunglasses (non-prescription including photosensitive)
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
18435685057961PackageGS18In Commercial Distribution
08435685057964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843568505796118435685057961
08435685057964084356850579648435685057964

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

Contacts#

Phone, Email table
PhoneEmail
305-879-1094anita.haudebert@etnia.es

Regulatory Flags#

DUNS number
148350593
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18435304397959ETNIA EYEWEAR CULTURE4 KASS.2 54O BKGR2022-12-07
18435304398604ETNIA EYEWEAR CULTURE4 KASS.2 58O BKGR2022-12-07
18435304398611ETNIA EYEWEAR CULTURE4 KASS.2 58O RD2022-12-07
18435304398628ETNIA EYEWEAR CULTURE4 KASS.2 58O BRBL2022-12-07
18435304398635ETNIA EYEWEAR CULTURE4 KASS.2 56O BLHV2022-12-07
18435304398659ETNIA EYEWEAR CULTURE4 KASS.2 56O RD2022-12-07
18435304398680ETNIA EYEWEAR CULTURE4 LEIPZG 55O BKRD2022-12-07
18435304398710ETNIA EYEWEAR CULTURE4 LEIPZG 53O BL2022-12-07
18435304398734ETNIA EYEWEAR CULTURE4 LEIPZG 53O BKOG2022-12-07
18435628701159ETNIA EYEWEAR CULTURE5 LAGAVI 49O HVBR2022-12-07
18435628701272ETNIA EYEWEAR CULTURE5 MISDI2 47O YWHV2022-12-07
18435628701302ETNIA EYEWEAR CULTURE5 KALLI2 49O BL2022-12-07
18435628701333ETNIA EYEWEAR CULTURE5 KALLI2 49O HVBR2022-12-07
18435628701340ETNIA EYEWEAR CULTURE5 BRYNNE 50O BKGR2022-12-07
18435628701357ETNIA EYEWEAR CULTURE5 BRYNNE 50O HVBL2022-12-07
18435628701364ETNIA EYEWEAR CULTURE5 BRYNNE 50O HVBR2022-12-07
18435628701371ETNIA EYEWEAR CULTURE5 BRYNNE 50O BKBE2022-12-07
18435628701555ETNIA EYEWEAR CULTURE5 PLA 47O BK2022-12-07
18435628701562ETNIA EYEWEAR CULTURE5 PLA 47O RDBL2022-12-07
18435628701579ETNIA EYEWEAR CULTURE5 PLA 47O HV2022-12-07

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