FDA.report

ETNIA EYEWEAR CULTURE

Primary DI
18435736041925
Brand
ETNIA EYEWEAR CULTURE
Company
Etnia Barcelona, Llc.
Model
4 YOKI 54O GRPT
Device description
Frame Spectacle
Published
2024-04-30
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

Product Codes

CodeName
HQZFrame, spectacle

Product Code Classifications

CodeDeviceSpecialtyClass
HQZFrame, SpectacleOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
18435736041925PackageGS110In Commercial Distribution
08435736041928PrimaryGS10

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
+1(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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18435646295333ETNIA EYEWEAR CULTURE5 RAVAL 53D HVWH2025-12-18
18435736092095ETNIA EYEWEAR CULTURE5 MISDI3 47O BK2025-12-18
18435736092132ETNIA EYEWEAR CULTURE5 MISDI3 47O GYGR2025-12-18
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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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00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
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00840322905504Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905511Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905528Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905535Zero G EyewearZero G EyewearHQZ2026-03-01
03701629014115Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014122Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014139Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014146Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
03701629014153Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-02-27
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