FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18447504009518
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 MA41.B 53O BK
Device description
Frame Spectacle
Published
2025-12-18
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

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
18447504009518PackageGS110In Commercial Distribution
08447504009511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750400951818447504009518
08447504009511084475040095118447504009511

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).

Sterilization Methods#

Method table
Method

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
08435736092777ETNIA EYEWEAR CULTURE5 CONSTA 54O DBBL2026-06-23
08435736092814ETNIA EYEWEAR CULTURE5 CONSTA 54O GRPK2026-06-23
08435736092852ETNIA EYEWEAR CULTURE5 CONSTA 54O OGTQ2026-06-23
08435736092890ETNIA EYEWEAR CULTURE5 CONSTA 54O BKWH2026-06-23
08435736092937ETNIA EYEWEAR CULTURE5 CONSTA 56O GRPK2026-06-23
08435736092975ETNIA EYEWEAR CULTURE5 CONSTA 56O DBBL2026-06-23
08435736093019ETNIA EYEWEAR CULTURE5 CONSTA 56O BKWH2026-06-23
08435736093057ETNIA EYEWEAR CULTURE5 CONSTA 56O OGTQ2026-06-23
08435736096072ETNIA EYEWEAR CULTURE5 CHR023 49O BLHV2026-06-23
08435736096119ETNIA EYEWEAR CULTURE5 CHR023 49O BRHV2026-06-23
08435736096157ETNIA EYEWEAR CULTURE5 CHR023 49O BXRD2026-06-23
08435736096195ETNIA EYEWEAR CULTURE5 CHR023 49O WH2026-06-23
08435736096232ETNIA EYEWEAR CULTURE5 CHR021 53O DBBL2026-06-23
08435736096270ETNIA EYEWEAR CULTURE5 CHR021 53O RD2026-06-23
08435736096317ETNIA EYEWEAR CULTURE5 CHR021 53O HVWH2026-06-23
08435736096355ETNIA EYEWEAR CULTURE5 CHR021 53O BK2026-06-23
08435736096393ETNIA EYEWEAR CULTURE5 CHR022 52O TQDB2026-06-23
08435736096430ETNIA EYEWEAR CULTURE5 CHR022 52O PUHV2026-06-23
08435736096478ETNIA EYEWEAR CULTURE5 CHR022 52O HV2026-06-23
08435736096515ETNIA EYEWEAR CULTURE5 CHR022 52O BRBE2026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04066209026032FielmannFielmann Group AGHQZ2026-07-08
04066209033016FielmannFielmann Group AGHQZ2026-07-08
04066209033184FielmannFielmann Group AGHQZ2026-07-08
04066209040083FielmannFielmann Group AGHQZ2026-07-08
04066209044883FielmannFielmann Group AGHQZ2026-07-08
04066209046917FielmannFielmann Group AGHQZ2026-07-08
04066209046924FielmannFielmann Group AGHQZ2026-07-08
04066209047051FielmannFielmann Group AGHQZ2026-07-08
04066209049178FielmannFielmann Group AGHQZ2026-07-08
04066209051140FielmannFielmann Group AGHQZ2026-07-08
04066209051201FielmannFielmann Group AGHQZ2026-07-08
04066209052475FielmannFielmann Group AGHQZ2026-07-08
04066209052673FielmannFielmann Group AGHQZ2026-07-08
04066209052697FielmannFielmann Group AGHQZ2026-07-08
04066209052932FielmannFielmann Group AGHQZ2026-07-08
04066209055445FielmannFielmann Group AGHQZ2026-07-08
04066209055803FielmannFielmann Group AGHQZ2026-07-08
04066209056213FielmannFielmann Group AGHQZ2026-07-08
04066209058637FielmannFielmann Group AGHQZ2026-07-08
04066209058644FielmannFielmann Group AGHQZ2026-07-08
04066209058934FielmannFielmann Group AGHQZ2026-07-08
04066209059795FielmannFielmann Group AGHQZ2026-07-08
04066209060074FielmannFielmann Group AGHQZ2026-07-08
04066209060081FielmannFielmann Group AGHQZ2026-07-08
04066209060425FielmannFielmann Group AGHQZ2026-07-08
04066209060487FielmannFielmann Group AGHQZ2026-07-08
04066209060517FielmannFielmann Group AGHQZ2026-07-08
04066209063525FielmannFielmann Group AGHQZ2026-07-08
04066209063600FielmannFielmann Group AGHQZ2026-07-08
03701629014160Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-07