FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
08435736091770
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
6 NEIL 54O DB
Device description
Frame Spectacle
Published
2026-08-08
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
18435736091777PackageGS110In Commercial Distribution
08435736091770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843573609177718435736091777
08435736091770084357360917708435736091770

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
08435736091299ETNIA EYEWEAR CULTURE6 HORNET 49O PTOG2026-08-08
08435736091336ETNIA EYEWEAR CULTURE6 HORNET 49O DGGR2026-08-08
08435736091374ETNIA EYEWEAR CULTURE6 HORNET 49O DB2026-08-08
08435736091411ETNIA EYEWEAR CULTURE6 HORNET 49O BK2026-08-08
08435736091459ETNIA EYEWEAR CULTURE6 MAE 51O GRBX2026-08-08
08435736091497ETNIA EYEWEAR CULTURE6 MAE 51O BXCO2026-08-08
08435736091534ETNIA EYEWEAR CULTURE6 MAE 51O BK2026-08-08
08435736091572ETNIA EYEWEAR CULTURE6 MAE 51O DBSK2026-08-08
08435736091619ETNIA EYEWEAR CULTURE6 EILEEN 49O PTGR2026-08-08
08435736091657ETNIA EYEWEAR CULTURE6 EILEEN 49O BKBZ2026-08-08
08435736091695ETNIA EYEWEAR CULTURE6 EILEEN 49O DBSK2026-08-08
08435736091732ETNIA EYEWEAR CULTURE6 EILEEN 49O BXPK2026-08-08
08435736091817ETNIA EYEWEAR CULTURE6 NEIL 54O BKGR2026-08-08
08435736091855ETNIA EYEWEAR CULTURE6 NEIL 54O PTAR2026-08-08
08435736091893ETNIA EYEWEAR CULTURE6 NEIL 54O GMRD2026-08-08
08435736091930ETNIA EYEWEAR CULTURE6 NEIL 56O BKGR2026-08-08
08435736091978ETNIA EYEWEAR CULTURE6 NEIL 56O PTAR2026-08-08
08435736092012ETNIA EYEWEAR CULTURE6 NEIL 56O GMRD2026-08-08
08435736092050ETNIA EYEWEAR CULTURE6 NEIL 56O DB2026-08-08
08447504002178ETNIA EYEWEAR CULTURE6 BYTE 54O DGAR2026-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435736091299ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091336ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091374ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091411ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091459ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091497ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091534ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091572ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091619ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091657ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091695ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091732ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091817ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091855ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091893ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091930ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736091978ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736092012ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08435736092050ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002178ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002215ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002253ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002291ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002338ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002376ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002413ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002451ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002499ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002574ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08
08447504002659ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2026-08-08