FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435736004029
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 CUBA 53S BLBK
Device description
Sunglasses (non-prescriptionincluding photosensitive)
Published
2024-07-07
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
18435736004029PackageGS18In Commercial Distribution
08435736004022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843573600402918435736004029
08435736004022084357360040228435736004022

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
08447504028307ETNIA EYEWEAR CULTURE4 ENRIC 55O GRHV2026-08-26
08447504028345ETNIA EYEWEAR CULTURE4 ENRIC 55O BZPT2026-08-26
08447504028383ETNIA EYEWEAR CULTURE4 ENRIC 55O DBBL2026-08-26
08447504028420ETNIA EYEWEAR CULTURE4 ENRIC 55O BKRD2026-08-26
08447504029342ETNIA EYEWEAR CULTURE4 ENRIC 57O DBBL2026-08-26
08447504029380ETNIA EYEWEAR CULTURE4 ENRIC 57O GRHV2026-08-26
08447504029427ETNIA EYEWEAR CULTURE4 ENRIC 57O BZPT2026-08-26
08447504029465ETNIA EYEWEAR CULTURE4 ENRIC 57O BKRD2026-08-26
08447504031529ETNIA EYEWEAR CULTURE4 KASS.3 56O PTHV2026-08-26
08447504031567ETNIA EYEWEAR CULTURE4 KASS.3 56O GMOG2026-08-26
08447504031604ETNIA EYEWEAR CULTURE4 KASS.3 56O GRRD2026-08-26
08447504031642ETNIA EYEWEAR CULTURE4 KASS.3 56O DB2026-08-26
08447504032007ETNIA EYEWEAR CULTURE4 BWHALE 48O DB2026-08-26
08447504032045ETNIA EYEWEAR CULTURE4 BWHALE 48O PTHV2026-08-26
08447504032083ETNIA EYEWEAR CULTURE4 BWHALE 48O AR2026-08-26
08447504032120ETNIA EYEWEAR CULTURE4 BWHALE 48O BZBK2026-08-26
08447504032168ETNIA EYEWEAR CULTURE4 KASS.3 54O DB2026-08-26
08447504032205ETNIA EYEWEAR CULTURE4 KASS.3 54O PTHV2026-08-26
08447504032243ETNIA EYEWEAR CULTURE4 KASS.3 54O GMOG2026-08-26
08447504032281ETNIA EYEWEAR CULTURE4 KASS.3 54O GRRD2026-08-26

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