FDA.report

ETNIA EYEWEAR CULTURE

Primary DI
18435646288755
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona LLC
Model
8 HUXLE 52S 00 YWH/P
Device description
Sunglasses (non-prescription including photosensitive)
Published
2022-12-06
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

Related Records

Contact Domains

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18435646288755PackageGS18In Commercial Distribution
08435646288758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1843564628875518435646288755
08435646288758084356462887588435646288758

GMDN Terms

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

Contacts

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 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 DIBrandCompanyProduct codePublished
06973541158162SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158179SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158186SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158193SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158209SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158216SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158223SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158230SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158247SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158254SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158261SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158278SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158285SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158292SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
06973541158308SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-05-26
08800332269531Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269548Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269586Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269593Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269616Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269623Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269630Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269647Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269654Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269661Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269678Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269685Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269692Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269708Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22
08800332269715Blue ElephantBlue Elephant Co.,Ltd.HQY2026-05-22