FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08447504026266
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 PALA2 48D YW
Device description
Frame Spectacle
Published
2026-08-19
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
18447504026263PackageGS110In Commercial Distribution
08447504026266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750402626318447504026263
08447504026266084475040262668447504026266

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
08435736028646ETNIA EYEWEAR CULTURE5 NILA 54D PUBL2026-08-19
08435736028721ETNIA EYEWEAR CULTURE5 NILA 54D HVBX2026-08-19
08435736090698ETNIA EYEWEAR CULTURE5 NILA 54D BKHV2026-08-19
08435736090759ETNIA EYEWEAR CULTURE5 NILA 54D TQHV2026-08-19
08447504026327ETNIA EYEWEAR CULTURE5 PALA2 51D YW2026-08-19
08447504042976ETNIA EYEWEAR CULTURE1 HANDUO 49O BKOG2026-08-19
08447504043010ETNIA EYEWEAR CULTURE1 HANDUO 49O BRGR2026-08-19
08447504043058ETNIA EYEWEAR CULTURE1 HANDUO 49O BLBL2026-08-19
08447504043096ETNIA EYEWEAR CULTURE1 HANDUO 49O RDRD2026-08-19
08435736088213ETNIA EYEWEAR CULTURE5 FLORID 55D BRBE2026-08-18
08435736088275ETNIA EYEWEAR CULTURE5 FLORID 55D BKHV2026-08-18
08435736088336ETNIA EYEWEAR CULTURE5 FLORID 55D PKHV2026-08-18
08435736088398ETNIA EYEWEAR CULTURE5 FLORID 55D GRYW2026-08-18
08435736088534ETNIA EYEWEAR CULTURE5 AVINY3 51D BKOG2026-08-18
08435736088596ETNIA EYEWEAR CULTURE5 AVINY3 51D GRHV2026-08-18
08435736088732ETNIA EYEWEAR CULTURE5 AMBOY 52D BEGR2026-08-18
08435736088794ETNIA EYEWEAR CULTURE5 AMBOY 52D BKPT2026-08-18
08435736088855ETNIA EYEWEAR CULTURE5 AMBOY 52D BK2026-08-18
08435736088916ETNIA EYEWEAR CULTURE5 AMBOY 52D HVBK2026-08-18
08435736088978ETNIA EYEWEAR CULTURE5 BELLEM 55D HVPT2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435736028646ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736028721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090698ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736090759ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504026327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504042976ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043010ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043058ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08447504043096ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-19
08435736088213ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088275ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088398ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088596ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088794ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088916ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736088978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089036ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089098ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736089159ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090810ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090872ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090933ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736090995ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091053ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091114ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18
08435736091176ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-18