FDA.report

EYEWEAR BY ROI KOKIA BLACK

Primary DI
00748474331779
Brand
EYEWEAR BY ROI KOKIA BLACK
Company
Eyewear By Roi, Limited
Model
1
Device description
53-17-135 BLACK KAREN KANE
Published
2022-10-20
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
00748474331779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00748474331779007484743317797484743317790748474331779

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(480)905-8020customerservice@eyewearbyroi.com

Regulatory Flags

DUNS number
177953189
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00748474312600EYEWEAR BY ROI SYDNEY BROWN12022-10-20
00748474312617EYEWEAR BY ROI SYDNEY DARK GUNMETAL12022-10-20
00748474314420EYEWEAR BY ROI OLEANDER GUNMETAL12022-10-20
00748474314604EYEWEAR BY ROI ANNECY DARK LILAC12022-10-20
00748474314611EYEWEAR BY ROI ANNECY ROSE12022-10-20
00748474315106EYEWEAR BY ROI OLEANDER SOFT BURGUNDY12022-10-20
00748474315571EYEWEAR BY ROI IXTAPA HAVANA/MINT12022-10-20
00748474316936EYEWEAR BY ROI IXTAPA BLACK/PURPLE12022-10-20
00748474319210EYEWEAR BY ROI WOOD ROSE MOCHA12022-10-20
00748474319234EYEWEAR BY ROI WOOD ROSE CRANBERRY12022-10-20
00748474319647EYEWEAR BY ROI SONYA BLACK12022-10-20
00748474319654EYEWEAR BY ROI SONYA MOCHA12022-10-20
00748474319715EYEWEAR BY ROI MASSY TORTOISE12022-10-20
00748474320513EYEWEAR BY ROI GARDENIA BROWN12022-10-20
00748474321176EYEWEAR BY ROI BELLA VISTA BROWN12022-10-20
00748474321183EYEWEAR BY ROI BELLA VISTA ROSE12022-10-20
00748474321442EYEWEAR BY ROI FAIRY MOSS BROWN/TEAL12022-10-20
00748474321534EYEWEAR BY ROI ARCHER HEIGHTS BLACK12022-10-20
00748474321541EYEWEAR BY ROI ARCHER HEIGHTS TORT/MINT12022-10-20
00748474321572EYEWEAR BY ROI ASHBURN BROWN12022-10-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
04066209019980FielmannFielmann Group AGHQZ2026-02-11