FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08447504032007
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
4 BWHALE 48O DB
Device description
Frame Spectacle
Published
2026-08-26
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
18447504032004PackageGS110In Commercial Distribution
08447504032007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750403200418447504032004
08447504032007084475040320078447504032007

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
888-553-8642anita.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
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
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
08447504035176ETNIA EYEWEAR CULTURE4 AGORA 53O DB2026-08-26

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
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
08447504037972ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-26