FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435685045494
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
3 SAN C. 55S GDRD
Device description
Sunglasses (non-prescriptionincluding photosensitive)
Published
2023-07-20
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
18435685045494PackageGS18In Commercial Distribution
08435685045497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843568504549418435685045494
08435685045497084356850454978435685045497

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
+1(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
08435304380985ETNIA EYEWEAR CULTURE4 SUNSET 47O HVGD2025-12-18
08435304381944ETNIA EYEWEAR CULTURE4 SUNSET 49O HVGD2025-12-18
08435646295336ETNIA EYEWEAR CULTURE5 RAVAL 53D HVWH2025-12-18
08435736092098ETNIA EYEWEAR CULTURE5 MISDI3 47O BK2025-12-18
08435736092135ETNIA EYEWEAR CULTURE5 MISDI3 47O GYGR2025-12-18
08435736092210ETNIA EYEWEAR CULTURE5 MISDI3 47O YWHV2025-12-18
08435736092258ETNIA EYEWEAR CULTURE5 ESMERC 52O RD2025-12-18
08435736092296ETNIA EYEWEAR CULTURE5 ESMERC 52O GRBR2025-12-18
08435736092333ETNIA EYEWEAR CULTURE5 ESMERC 52O HVRD2025-12-18
08435736092371ETNIA EYEWEAR CULTURE5 ESMERC 52O BK2025-12-18
08447504002895ETNIA EYEWEAR CULTURE5 CHR028 52O BK2025-12-18
08447504002932ETNIA EYEWEAR CULTURE5 CHR028 52O DGGR2025-12-18
08447504002970ETNIA EYEWEAR CULTURE5 CHR028 52O YWHV2025-12-18
08447504003014ETNIA EYEWEAR CULTURE5 CHR028 52O PTHV2025-12-18
08447504003052ETNIA EYEWEAR CULTURE5 GARGAL 52O BLHV2025-12-18
08447504003090ETNIA EYEWEAR CULTURE5 GARGAL 52O HVOG2025-12-18
08447504003137ETNIA EYEWEAR CULTURE5 GARGAL 52O BKHV2025-12-18
08447504003175ETNIA EYEWEAR CULTURE5 GARGAL 52O GY2025-12-18
08447504003212ETNIA EYEWEAR CULTURE5 CABANY 50O PK2025-12-18
08447504003250ETNIA EYEWEAR CULTURE5 CABANY 50O GRHV2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054342061016Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061023Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061030Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061047Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061078Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061085Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061108Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342061115Bricola VeneziaMAD IN ITALY SRLHQY2026-04-14
08054342060927Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060934Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060958Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060965Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060972Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060989Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342060996Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342061061Bricola VeneziaMAD IN ITALY SRLHQY2026-04-13
08054342061849Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061856Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061863Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061870Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061887Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061894Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061900Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061917Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061924Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061931Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061948Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061955Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061962Mad in Italy MAD IN ITALY SRLHQY2026-04-13
08054342061979Mad in Italy MAD IN ITALY SRLHQY2026-04-13