FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08435685079164
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 WAYNES 60O HVPT
Device description
Frame Spectacle
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
18435685079161PackageGS110In Commercial Distribution
08435685079164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843568507916118435685079161
08435685079164084356850791648435685079164

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).

Contacts#

Phone, Email table
PhoneEmail
+1(305)879-1094anita.haudebert@etnia.es

Regulatory Flags#

DUNS number
148350593
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
08447504028307ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028345ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028383ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504028420ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029342ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029380ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029427ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504029465ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031529ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031567ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031604ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504031642ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032007ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032045ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032083ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032120ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032168ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032205ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032243ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504032281ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035251ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504035299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036777ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036814ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036852ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504036890ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037897ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26
08447504037934ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26