FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435736063590
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 AZEEZA 52O GR
Device description
Frame Spectacle
Published
2024-06-08
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
HQZFrame, Spectacle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18435736063590PackageGS110In Commercial Distribution
08435736063593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843573606359018435736063590
08435736063593084357360635938435736063593

GMDN Terms#

Term, Definition table
TermDefinition
Spectacle frameAn ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).

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
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
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30