FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08447504025702
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 KALLI3 52O GYHV
Device description
Frame Spectacle
Published
2026-08-02
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
18447504025709PackageGS110In Commercial Distribution
08447504025702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750402570918447504025709
08447504025702084475040257028447504025702

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
08435736087377ETNIA EYEWEAR CULTURE5 NEWMOO 53O DBOG2026-08-03
08435736087414ETNIA EYEWEAR CULTURE5 NEWMOO 53O GRYW2026-08-03
08435736087490ETNIA EYEWEAR CULTURE5 NEWMOO 53O GRHV2026-08-03
08435736088053ETNIA EYEWEAR CULTURE5 NARVAL 56O BLHV2026-08-03
08435736088091ETNIA EYEWEAR CULTURE5 NARVAL 56O GRHV2026-08-03
08435736088138ETNIA EYEWEAR CULTURE5 NARVAL 56O HV2026-08-03
08435736088176ETNIA EYEWEAR CULTURE5 NARVAL 56O BK2026-08-03
08435736098311ETNIA EYEWEAR CULTURE5 METEOR 55O BKPT2026-08-03
08435736098359ETNIA EYEWEAR CULTURE5 METEOR 55O HVBL2026-08-03
08435736098397ETNIA EYEWEAR CULTURE5 METEOR 55O OG2026-08-03
08435736098434ETNIA EYEWEAR CULTURE5 METEOR 55O GRBE2026-08-03
08447504002734ETNIA EYEWEAR CULTURE5 MARAGA 51O CL2026-08-03
08447504002772ETNIA EYEWEAR CULTURE5 MARAGA 51O BLHV2026-08-03
08447504002819ETNIA EYEWEAR CULTURE5 MARAGA 51O HVBR2026-08-03
08447504002857ETNIA EYEWEAR CULTURE5 MARAGA 51O BK2026-08-03
08447504026020ETNIA EYEWEAR CULTURE5 KREUZ3 49O HVBR2026-08-03
08447504027140ETNIA EYEWEAR CULTURE5 MISDI3 47O HVRD2026-08-03
08435736087537ETNIA EYEWEAR CULTURE5 HALFMO 51O HVTQ2026-08-01
08435736087575ETNIA EYEWEAR CULTURE5 HALFMO 51O ZEFU2026-08-01
08435736087612ETNIA EYEWEAR CULTURE5 HALFMO 51O CHPK2026-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435736087377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736087414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736087490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088091ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088138ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736088176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098311ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098359ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098397ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736098434ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002734ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002772ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002819ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504002857ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504026020ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08447504027140ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-03
08435736092616ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092654ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092692ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736092739ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097833ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097871ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097918ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08435736097956ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000617ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000693ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504000730ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504025740ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02
08447504025863ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-02