FDA.reportPublic FDA data

Artemis, Matte Tortoise, Grey Lens, Freshwater, Smoke

Primary DI
00840382311246
Brand
Artemis, Matte Tortoise, Grey Lens, Freshwater, Smoke
Company
Rlvnt, Inc.
Model
ART005-GR-HW008
Catalog number
ART005-GY-HW008
Device description
Sunglasses
Published
2024-06-14
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
HQYSunglasses (non-prescription including photosensitive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840382311246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840382311246008403823112468403823112460840382311246

GMDN Terms#

Term, Definition table
TermDefinition
Tinted non-prescription spectaclesAn optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)822-9300customerservice@rlvnt.life

Regulatory Flags#

DUNS number
092721469
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840382309601Navigator, Matte Black, Chameleon Lens, Freshwater, SmokeNAV001-CH-HW008NAV001-CH-HW0082024-06-14
00840382309656Outlander, Brown Gradient, Grey Lens, Freshwater, SunfireOUT012-GY-FW007OUT012-GY-FW0072024-06-14
00840382309670Outlander, Brown Gradient, Brown Lens, Freshwater, SmokeOUT012-BR-HW008OUT012-BR-HW0082024-06-14
00840382309687Outlander, Brown Gradient, Grey Lens, Freshwater, SmokeOUT012-GY-HW008OUT012-GY-HW0082024-06-14
00840382309694Outlander, Matte Black, Chameleon Lens, Freshwater, SunfireOUT001-CH-FW007OUT001-CH-FW0072024-06-14
00840382309762Outlander, Shiny Wine, Brown Lens, Freshwater, SunfireOUT009-BR-FW007OUT009-BR-FW0072024-06-14
00840382309816Ranger, Matte Black, Chameleon Lens, Freshwater, SunfireRGR001-CH-FW007RGY001-CH-FW0072024-06-14
00840382309861Ranger, Matte Black, Grey Lens, Freshwater, SmokeRGR001-GY-HW008RGY001-GY-HW0082024-06-14
00840382309915Ranger, Matte Grey, Brown Lens, Freshwater, SmokeRGR004-BR-HW008RGY004-BR-HW0082024-06-14
00840382309939Ranger, Matte Tortoise, Chameleon Lens, Freshwater, SunfireRGR005-CH-FW007RGY005-CH-FW0072024-06-14
00840382309946Ranger, Matte Tortoise, Brown Lens, Freshwater, SunfireRGR005-BR-FW007RGY005-BR-FW0072024-06-14
00840382310003Triton, Matte Black, Brown Lens, Freshwater, SunfireTTN001-BR-FW007TTN001-BR-FW0072024-06-14
00840382310027Triton, Matte Black, Chameleon Lens, Freshwater, SmokeTTN001-CH-HW008TTN001-CH-HW0082024-06-14
00840382310034Triton, Matte Black, Brown Lens, Freshwater, SmokeTTN001-BR-HW008TTN001-BR-HW0082024-06-14
00840382310096Triton, Matte Navy, Brown Lens, Freshwater, SmokeTTN003-BR-HW008TTN003-BR-HW0082024-06-14
00840382310133Triton, Matte Brown, Grey Lens, Freshwater, SunfireTTN002-GY-FW007TTN002-GY-FW0072024-06-14
00840382310157Triton, Matte Brown, Brown Lens, Freshwater, SmokeTTN002-BR-HW008TTN002-BR-HW0082024-06-14
00840382310171Sunchaser, Matte Black, Chameleon Lens, Freshwater, SunfireSUN001-CH-FW007SUN001-CH-FW0072024-06-14
00840382310188Sunchaser, Matte Black, Brown Lens, Freshwater, SunfireSUN001-BR-FW007SUN001-BR-FW0072024-06-14
00840382310249Sunchaser, Translucent Brown, Brown Lens, Freshwater, SunfireSUN022-BR-FW007SUN022-BR-FW0072024-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06973541158346SunglassesTaizhou YuanMing Glasses Co., LtdHQY2026-06-02
08800332269951Blue ElephantBlue Elephant Co.,Ltd.HQY2026-06-02
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00881814539975Superflex Sun CollectionWestGroupe Optical IncHQY2026-06-01
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