FDA.report

ETNIA EYEWEAR CULTURE

Primary DI
18435685083229
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
5 BRIDGE 52S BK
Device description
Sunglasses (non-prescriptionincluding photosensitive)
Published
2022-12-08
Public version status
Update
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
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18435685083229PackageGS18In Commercial Distribution
08435685083222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1843568508322918435685083229
08435685083222084356850832228435685083222

GMDN Terms

TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

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

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18435304380982ETNIA EYEWEAR CULTURE4 SUNSET 47O HVGD2025-12-18
18435304381941ETNIA EYEWEAR CULTURE4 SUNSET 49O HVGD2025-12-18
18435646295333ETNIA EYEWEAR CULTURE5 RAVAL 53D HVWH2025-12-18
18435736092095ETNIA EYEWEAR CULTURE5 MISDI3 47O BK2025-12-18
18435736092132ETNIA EYEWEAR CULTURE5 MISDI3 47O GYGR2025-12-18
18435736092217ETNIA EYEWEAR CULTURE5 MISDI3 47O YWHV2025-12-18
18435736092255ETNIA EYEWEAR CULTURE5 ESMERC 52O RD2025-12-18
18435736092293ETNIA EYEWEAR CULTURE5 ESMERC 52O GRBR2025-12-18
18435736092330ETNIA EYEWEAR CULTURE5 ESMERC 52O HVRD2025-12-18
18435736092378ETNIA EYEWEAR CULTURE5 ESMERC 52O BK2025-12-18
18447504002892ETNIA EYEWEAR CULTURE5 CHR028 52O BK2025-12-18
18447504002939ETNIA EYEWEAR CULTURE5 CHR028 52O DGGR2025-12-18
18447504002977ETNIA EYEWEAR CULTURE5 CHR028 52O YWHV2025-12-18
18447504003011ETNIA EYEWEAR CULTURE5 CHR028 52O PTHV2025-12-18
18447504003059ETNIA EYEWEAR CULTURE5 GARGAL 52O BLHV2025-12-18
18447504003097ETNIA EYEWEAR CULTURE5 GARGAL 52O HVOG2025-12-18
18447504003134ETNIA EYEWEAR CULTURE5 GARGAL 52O BKHV2025-12-18
18447504003172ETNIA EYEWEAR CULTURE5 GARGAL 52O GY2025-12-18
18447504003219ETNIA EYEWEAR CULTURE5 CABANY 50O PK2025-12-18
18447504003257ETNIA EYEWEAR CULTURE5 CABANY 50O GRHV2025-12-18

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