FDA.reportPublic FDA data

EYEWEAR BY ROI GARDENIA BROWN

Primary DI
00748474320513
Brand
EYEWEAR BY ROI GARDENIA BROWN
Company
Eyewear By Roi, Limited
Model
1
Device description
51-16-135 BROWN KAREN KANE
Published
2022-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00748474320513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748474320513007484743205137484743205130748474320513

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

Contacts#

Phone, Email table
PhoneEmail
+1(480)905-8020customerservice@eyewearbyroi.com

Regulatory Flags#

DUNS number
177953189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
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
00748474321589EYEWEAR BY ROI ASHBURN WINE12022-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800348921041Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921058Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921096Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
08800348921102Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-22
03701629015006Pierre EyewearNEW INTERNATIONAL VISIONHQZ2026-07-21
08800348920501Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920518Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920587Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920594Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920600Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920617Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920662Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920679Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920716Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920723Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920730Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920778Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920785Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
08800348920860Blue ElephantBlue Elephant Co.,Ltd.HQZ2026-07-20
04066209006799FielmannFielmann Group AGHQZ2026-07-14
04066209008311FielmannFielmann Group AGHQZ2026-07-14
04066209008885FielmannFielmann Group AGHQZ2026-07-14
04066209045118FielmannFielmann Group AGHQZ2026-07-14
04066209054578FielmannFielmann Group AGHQZ2026-07-14
04580822703694EYEVANEYEVAN INC.HQZ2026-07-10
04580822703724EYEVANEYEVAN INC.HQZ2026-07-10
04580822703731EYEVANEYEVAN INC.HQZ2026-07-10
04580822703748EYEVANEYEVAN INC.HQZ2026-07-10
04580822704264EYEVANEYEVAN INC.HQZ2026-07-10
04580822704271EYEVANEYEVAN INC.HQZ2026-07-10