FDA.reportPublic FDA data

ETNIA EYEWEAR CULTURE

Primary DI
18435304398680
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona LLC
Model
4 LEIPZG 55O 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
18435304398680PackageGS110In Commercial Distribution
08435304398683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1843530439868018435304398680
08435304398683084353043986838435304398683

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
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
18435628701586ETNIA EYEWEAR CULTURE5 PLA 47O YWHV2022-12-07

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