FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435628704013
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona LLC
Model
4 POWWOW 48O BKRD
Device description
Frame Spectacle
Published
2022-12-07
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
18435628704013PackageGS110In Commercial Distribution
08435628704016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843562870401318435628704013
08435628704016084356287040168435628704016

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

Contacts#

Phone, Email table
PhoneEmail
305-879-1094anita.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
18435304397959ETNIA EYEWEAR CULTURE4 KASS.2 54O BKGR2022-12-07
18435304398604ETNIA EYEWEAR CULTURE4 KASS.2 58O BKGR2022-12-07
18435304398611ETNIA EYEWEAR CULTURE4 KASS.2 58O RD2022-12-07
18435304398628ETNIA EYEWEAR CULTURE4 KASS.2 58O BRBL2022-12-07
18435304398635ETNIA EYEWEAR CULTURE4 KASS.2 56O BLHV2022-12-07
18435304398659ETNIA EYEWEAR CULTURE4 KASS.2 56O RD2022-12-07
18435304398680ETNIA EYEWEAR CULTURE4 LEIPZG 55O BKRD2022-12-07
18435304398710ETNIA EYEWEAR CULTURE4 LEIPZG 53O BL2022-12-07
18435304398734ETNIA EYEWEAR CULTURE4 LEIPZG 53O BKOG2022-12-07
18435628701159ETNIA EYEWEAR CULTURE5 LAGAVI 49O HVBR2022-12-07
18435628701272ETNIA EYEWEAR CULTURE5 MISDI2 47O YWHV2022-12-07
18435628701302ETNIA EYEWEAR CULTURE5 KALLI2 49O BL2022-12-07
18435628701333ETNIA EYEWEAR CULTURE5 KALLI2 49O HVBR2022-12-07
18435628701340ETNIA EYEWEAR CULTURE5 BRYNNE 50O BKGR2022-12-07
18435628701357ETNIA EYEWEAR CULTURE5 BRYNNE 50O HVBL2022-12-07
18435628701364ETNIA EYEWEAR CULTURE5 BRYNNE 50O HVBR2022-12-07
18435628701371ETNIA EYEWEAR CULTURE5 BRYNNE 50O BKBE2022-12-07
18435628701555ETNIA EYEWEAR CULTURE5 PLA 47O BK2022-12-07
18435628701562ETNIA EYEWEAR CULTURE5 PLA 47O RDBL2022-12-07
18435628701579ETNIA EYEWEAR CULTURE5 PLA 47O HV2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30