FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435736022870
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 GORGON 51S BL
Device description
Sunglasses (non-prescriptionincluding photosensitive)
Published
2024-07-05
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
18435736022870PackageGS18In Commercial Distribution
08435736022873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843573602287018435736022870
08435736022873084357360228738435736022873

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
04580822704165EYEVANEYEVAN INC.HQY2026-07-10
04580822704172EYEVANEYEVAN INC.HQY2026-07-10
04580822704189EYEVANEYEVAN INC.HQY2026-07-10
04580822704196EYEVANEYEVAN INC.HQY2026-07-10
04580822704660EYEVANEYEVAN INC.HQY2026-07-10
04580822704677EYEVANEYEVAN INC.HQY2026-07-10
04580822704684EYEVANEYEVAN INC.HQY2026-07-10
04580822704691EYEVANEYEVAN INC.HQY2026-07-10
04580822704707EYEVANEYEVAN INC.HQY2026-07-10
04580822705148EYEVANEYEVAN INC.HQY2026-07-10
04580822705155EYEVANEYEVAN INC.HQY2026-07-10
04580822705162EYEVANEYEVAN INC.HQY2026-07-10
04580822705179EYEVANEYEVAN INC.HQY2026-07-10
04580822705186EYEVANEYEVAN INC.HQY2026-07-10
04580822705193EYEVANEYEVAN INC.HQY2026-07-10
04580822705223EYEVANEYEVAN INC.HQY2026-07-10
04580822705230EYEVANEYEVAN INC.HQY2026-07-10
04582669067885E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067892E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067908E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067915E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067922E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068417E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068424E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068455E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068462E5 eyevanEYEVAN INC.HQY2026-07-10
04582669069384EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069391EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069407EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069582EYEVAN7285EYEVAN INC.HQY2026-07-10