FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08447504033974
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 CHR040 48O HVVI
Device description
Frame Spectacle
Published
2026-10-22
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
18447504033971PackageGS110In Commercial Distribution
08447504033974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750403397118447504033971
08447504033974084475040339748447504033974

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
08447504030140ETNIA EYEWEAR CULTURE5 CARLOS 51O BROG2026-10-22
08447504030188ETNIA EYEWEAR CULTURE5 CARLOS 51O GR2026-10-22
08447504030225ETNIA EYEWEAR CULTURE5 CARLOS 51O TQBR2026-10-22
08447504030263ETNIA EYEWEAR CULTURE5 CARLOS 51O HVBK2026-10-22
08447504030560ETNIA EYEWEAR CULTURE5 ANCORA 54O BKPK2026-10-22
08447504030607ETNIA EYEWEAR CULTURE5 ANCORA 54O BRBE2026-10-22
08447504030645ETNIA EYEWEAR CULTURE5 ANCORA 54O RDHV2026-10-22
08447504030683ETNIA EYEWEAR CULTURE5 CORAL 53O PUPK2026-10-22
08447504030720ETNIA EYEWEAR CULTURE5 CORAL 53O DBHV2026-10-22
08447504030768ETNIA EYEWEAR CULTURE5 CORAL 53O HVOG2026-10-22
08447504030805ETNIA EYEWEAR CULTURE5 ANCORA 56O BKPK2026-10-22
08447504030843ETNIA EYEWEAR CULTURE5 ANCORA 56O BRBE2026-10-22
08447504030881ETNIA EYEWEAR CULTURE5 ANCORA 56O RDHV2026-10-22
08447504033899ETNIA EYEWEAR CULTURE5 CHR040 48O BKRD2026-10-22
08447504033936ETNIA EYEWEAR CULTURE5 CHR040 48O HVGR2026-10-22
08447504034018ETNIA EYEWEAR CULTURE5 CHR040 48O BL2026-10-22
08447504034056ETNIA EYEWEAR CULTURE5 CHR043 48O HVBL2026-10-22
08447504034094ETNIA EYEWEAR CULTURE5 CHR043 48O BKHV2026-10-22
08447504034131ETNIA EYEWEAR CULTURE5 CHR043 48O WHCL2026-10-22
08447504034179ETNIA EYEWEAR CULTURE5 CHR043 48O VIOG2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08447504030683ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030720ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030768ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030805ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030843ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504030881ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033899ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504033936ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034018ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034056ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034094ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034131ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034179ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034216ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034254ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034292ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034339ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034377ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034414ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034452ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034490ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034537ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22
08447504034575ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-10-22