FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08435736096119
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 CHR023 49O BRHV
Device description
Frame Spectacle
Published
2026-06-23
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
18435736096116PackageGS110In Commercial Distribution
08435736096119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843573609611618435736096116
08435736096119084357360961198435736096119

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
08435736097772ETNIA BARCELONA5 SAROQU 54D BEBR2026-07-28
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
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
04582647307729MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307736MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307743MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307750MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307767MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307774MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307781MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307798MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307804MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307811MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307828MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307835MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307842MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307859MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307866MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307873MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307880MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307897MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307903MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307910MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307927MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307934MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307941MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307958MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647307965MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308009MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308016MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308023MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308030MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30
04582647308047MASUNAGA since 1905MASUNAGA OPTICAL MFG.CO.,LTD.HQZ2026-07-30