FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435685097875
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 CAROL 52S BXGR
Device description
Sunglasses (non-prescriptionincluding photosensitive)
Published
2022-12-08
Public version status
Update
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
18435685097875PackageGS18In Commercial Distribution
08435685097878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843568509787518435685097875
08435685097878084356850978788435685097878

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
08435736092777ETNIA EYEWEAR CULTURE5 CONSTA 54O DBBL2026-06-23
08435736092814ETNIA EYEWEAR CULTURE5 CONSTA 54O GRPK2026-06-23
08435736092852ETNIA EYEWEAR CULTURE5 CONSTA 54O OGTQ2026-06-23
08435736092890ETNIA EYEWEAR CULTURE5 CONSTA 54O BKWH2026-06-23
08435736092937ETNIA EYEWEAR CULTURE5 CONSTA 56O GRPK2026-06-23
08435736092975ETNIA EYEWEAR CULTURE5 CONSTA 56O DBBL2026-06-23
08435736093019ETNIA EYEWEAR CULTURE5 CONSTA 56O BKWH2026-06-23
08435736093057ETNIA EYEWEAR CULTURE5 CONSTA 56O OGTQ2026-06-23
08435736096072ETNIA EYEWEAR CULTURE5 CHR023 49O BLHV2026-06-23
08435736096119ETNIA EYEWEAR CULTURE5 CHR023 49O BRHV2026-06-23
08435736096157ETNIA EYEWEAR CULTURE5 CHR023 49O BXRD2026-06-23
08435736096195ETNIA EYEWEAR CULTURE5 CHR023 49O WH2026-06-23
08435736096232ETNIA EYEWEAR CULTURE5 CHR021 53O DBBL2026-06-23
08435736096270ETNIA EYEWEAR CULTURE5 CHR021 53O RD2026-06-23
08435736096317ETNIA EYEWEAR CULTURE5 CHR021 53O HVWH2026-06-23
08435736096355ETNIA EYEWEAR CULTURE5 CHR021 53O BK2026-06-23
08435736096393ETNIA EYEWEAR CULTURE5 CHR022 52O TQDB2026-06-23
08435736096430ETNIA EYEWEAR CULTURE5 CHR022 52O PUHV2026-06-23
08435736096478ETNIA EYEWEAR CULTURE5 CHR022 52O HV2026-06-23
08435736096515ETNIA EYEWEAR CULTURE5 CHR022 52O BRBE2026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209038196FielmannFielmann Group AGHQY2026-07-06
04066209038202FielmannFielmann Group AGHQY2026-07-06
04066209038219FielmannFielmann Group AGHQY2026-07-06
04066209053885FielmannFielmann Group AGHQY2026-07-06
04066209060180FielmannFielmann Group AGHQY2026-07-06
04066209060197FielmannFielmann Group AGHQY2026-07-06
04066209060203FielmannFielmann Group AGHQY2026-07-06
04066209060265FielmannFielmann Group AGHQY2026-07-06
04066209060289FielmannFielmann Group AGHQY2026-07-06
04066209060388FielmannFielmann Group AGHQY2026-07-06
04066209060470FielmannFielmann Group AGHQY2026-07-06
04066209060845FielmannFielmann Group AGHQY2026-07-06
04066209061132FielmannFielmann Group AGHQY2026-07-06
04066209063570FielmannFielmann Group AGHQY2026-07-06
04066209064416FielmannFielmann Group AGHQY2026-07-06
04066209064430FielmannFielmann Group AGHQY2026-07-06
04066209064874FielmannFielmann Group AGHQY2026-07-06
06973541158131SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
16973541158138SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-07-06
06974213566148MalibuWENZHOU TIDE-OPTICAL CO.,LTDHQY2026-07-03
08800348920280Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920297Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920303Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920310Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920327Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920334Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920341Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920358Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920365Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25
08800348920372Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-25