FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18447504013140
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 OMAR 47D HVGR
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
18447504013140PackageGS110In Commercial Distribution
08447504013143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1844750401314018447504013140
08447504013143084475040131438447504013143

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
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
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04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10
04580822704288EYEVANEYEVAN INC.HQZ2026-07-10
04580822704295EYEVANEYEVAN INC.HQZ2026-07-10
04580822704561EYEVANEYEVAN INC.HQZ2026-07-10
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04580822704585EYEVANEYEVAN INC.HQZ2026-07-10
04580822704592EYEVANEYEVAN INC.HQZ2026-07-10
04580822704837EYEVANEYEVAN INC.HQZ2026-07-10
04580822704844EYEVANEYEVAN INC.HQZ2026-07-10
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04580822705018EYEVANEYEVAN INC.HQZ2026-07-10
04580822705025EYEVANEYEVAN INC.HQZ2026-07-10
04580822705049EYEVANEYEVAN INC.HQZ2026-07-10
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04582669065409EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065416EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065454EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065461EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065478EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065522EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065539EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065546EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10
04582669065553EYEVAN HISTORIC COLLECTIONEYEVAN INC.HQZ2026-07-10