FDA.report

ETNIA EYEWEAR CULTURE

Primary DI
18435646239108
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona LLC
Model
4 KEM 56O BKSL
Device description
Frame Spectacle
Published
2022-12-06
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

Related Records

Contact Domains

Product Codes

CodeName
HQZFrame, Spectacle

Product Code Classifications

CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18435646239108PackageGS110In Commercial Distribution
08435646239101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1843564623910818435646239108
08435646239101084356462391018435646239101

GMDN Terms

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

Contacts

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 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

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00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
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00840322905511Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905528Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905535Zero G EyewearZero G EyewearHQZ2026-03-01
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03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
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