FDA.reportPublic FDA data

EYEVAN

Primary DI
04582667981190
Brand
EYEVAN
Company
EYEVAN INC.
Model
MALECON 51 TORT
Published
2022-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04582667981190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582667981190045826679811904582667981190

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

Regulatory Flags#

DUNS number
705184505
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582669045456IVRIOTIVT201 54 2030-CL2026-03-26
04582669045463IVRIOTIVT201 54 1020-CL2026-03-26
04582669045470IVRIOTIVT201 54 3000-CL2026-03-26
04582669045487IVRIOTIVT201 54 1000-GY PH2026-03-26
04582669045494IVRIOTIVT201 54 2030-PK PH2026-03-26
04582669045500IVRIOTIVT201 54 1020-BL PH2026-03-26
04582669045517IVRIOTIVT201 54 3000-BR PH2026-03-26
04582669045531IVRIOTIVT202 51 1000-CL2026-03-26
04582669045548IVRIOTIVT202 51 2030-CL2026-03-26
04582669045555IVRIOTIVT202 51 1020-CL2026-03-26
04582669045562IVRIOTIVT202 51 3040-CL2026-03-26
04582669045579IVRIOTIVT202 51 1000-GY PH2026-03-26
04582669045586IVRIOTIVT202 51 2030-GY PH2026-03-26
04582669045593IVRIOTIVT202 51 1020-PK PH2026-03-26
04582669045609IVRIOTIVT202 51 3040-BL PH2026-03-26
04582669032869IVRIOTIVT100 48 101-CL2026-03-25
04582669032876IVRIOTIVT100 48 102-CL2026-03-25
04582669032890IVRIOTIVT101 49 101-CL2026-03-25
04582669032906IVRIOTIVT101 49 102-CL2026-03-25
04582669032920IVRIOTIVT102 50 101-CL2026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800332269944Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-05-22
00840322905481Zero G EyewearZero G EyewearHQZ2026-03-01
00840322905498Zero G EyewearZero G EyewearHQZ2026-03-01
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
04066209005051FielmannFielmann Group AGHQZ2026-02-11
04066209005341FielmannFielmann Group AGHQZ2026-02-11
04066209005358FielmannFielmann Group AGHQZ2026-02-11
04066209005389FielmannFielmann Group AGHQZ2026-02-11
04066209006034FielmannFielmann Group AGHQZ2026-02-11
04066209006041FielmannFielmann Group AGHQZ2026-02-11
04066209006089FielmannFielmann Group AGHQZ2026-02-11
04066209008182FielmannFielmann Group AGHQZ2026-02-11
04066209008199FielmannFielmann Group AGHQZ2026-02-11
04066209008205FielmannFielmann Group AGHQZ2026-02-11
04066209008212FielmannFielmann Group AGHQZ2026-02-11
04066209008229FielmannFielmann Group AGHQZ2026-02-11
04066209008236FielmannFielmann Group AGHQZ2026-02-11
04066209009424FielmannFielmann Group AGHQZ2026-02-11
04066209019669FielmannFielmann Group AGHQZ2026-02-11
04066209019676FielmannFielmann Group AGHQZ2026-02-11
04066209019683FielmannFielmann Group AGHQZ2026-02-11
04066209019867FielmannFielmann Group AGHQZ2026-02-11