FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08447504040736
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 DIONE 53O HV
Device description
Frame Spectacle
Published
2026-10-26
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
18447504040733PackageGS110In Commercial Distribution
08447504040736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750404073318447504040733
08447504040736084475040407368447504040736

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
08447504040095ETNIA EYEWEAR CULTURE5 DASOS 56O VIHO2026-10-26
08447504040132ETNIA EYEWEAR CULTURE5 DASOS 56O HVTQ2026-10-26
08447504040170ETNIA EYEWEAR CULTURE5 DASOS 56O BXHV2026-10-26
08447504040217ETNIA EYEWEAR CULTURE5 DASOS 56O BLDB2026-10-26
08447504040255ETNIA EYEWEAR CULTURE5 DASOS 56O HV2026-10-26
08447504040293ETNIA EYEWEAR CULTURE5 DASOS 56O BK2026-10-26
08447504040330ETNIA EYEWEAR CULTURE5 DASOS 56O GRBK2026-10-26
08447504040378ETNIA EYEWEAR CULTURE5 DASOS 56O RDBX2026-10-26
08447504040774ETNIA EYEWEAR CULTURE5 DIONE 53O BK2026-10-26
08447504040811ETNIA EYEWEAR CULTURE5 DIONE 53O CUGR2026-10-26
08447504040859ETNIA EYEWEAR CULTURE5 DIONE 53O BRPK2026-10-26
08447504040897ETNIA EYEWEAR CULTURE5 DIONE 53O BX2026-10-26
08447504040934ETNIA EYEWEAR CULTURE5 DIONE 53O PTPU2026-10-26
08447504040972ETNIA EYEWEAR CULTURE5 DIONE 53O BL2026-10-26
08447504041016ETNIA EYEWEAR CULTURE5 DIONE 53O PKBK2026-10-26
08447504041375ETNIA EYEWEAR CULTURE5 ELIA 54O BLHV2026-10-26
08447504041412ETNIA EYEWEAR CULTURE5 ELIA 54O HV2026-10-26
08447504041450ETNIA EYEWEAR CULTURE5 ELIA 54O BK2026-10-26
08447504041498ETNIA EYEWEAR CULTURE5 ELIA 54O GR2026-10-26
08447504041535ETNIA EYEWEAR CULTURE5 ELIA 54O HVTQ2026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08447504040095ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040132ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040170ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040217ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040255ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040293ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040330ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040378ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040774ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040811ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040859ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040897ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040934ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504040972ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041016ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041375ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041412ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041450ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041498ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041535ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041573ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041610ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504041658ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-26
08447504030140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030188ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030225ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030263ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030560ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030607ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030645ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22