FDA.reportPublic FDA data

EYEWEAR BY ROI DALE DARK GUNMETAL

Primary DI
00748474508812
Brand
EYEWEAR BY ROI DALE DARK GUNMETAL
Company
Eyewear By Roi, Limited
Model
1
Device description
54-19-135 DARK GUNMETAL BULOVA TWIST TITANIUM
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
00748474508812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00748474508812007484745088127484745088120748474508812

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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435304380985ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304381944ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2025-12-18
08435304375615ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375622ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304375639ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304379262ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388721ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304388745ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-31
08435304355259ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355266ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355273ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355310ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304355327ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-20
08435304361915ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361953ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-19
08435304361052ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361090ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361113ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361137ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-17
08435304361175ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-16
08435304361977ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304361991ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2024-07-10
08435304388806ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304389858ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304391165ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-10
08435304379279ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304383085ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304388585ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-12-04
08435304369003ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30
08435304379200ETNIA EYEWEAR CULTUREEtnia Barcelona, Llc.HQZ2022-11-30