FDA.reportPublic FDA data

RCI Optics

Primary DI
G358122002H780
Brand
RCI Optics
Company
RCI Optics
Model
REFUGE
Catalog number
122002H780
Device description
GRAPHITE GREY ATLANTIC BLUE MIRROR H780
Published
2022-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
G358122002H780PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
065413366
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G358142005H780RCI Optics9 Mile Bank142005H7802023-05-17
G358142006H780RCI Optics9 Mile Bank141806LTD2023-05-17
G358101503H780RCI OpticsANASTASIA101503H7802022-12-05
G358101703H780RCI OpticsANASTASIA101703H7802022-12-05
G358101902H780RCI OpticsANASTASIA101902H7802022-12-05
G358111002H780RCI OpticsPUMP HOUSE111002H7802022-12-05
G358111003H780RCI OpticsPUMP HOUSE111003H7802022-12-05
G358112002H780RCI OpticsPUMP HOUSE112002H7802022-12-05
G358112003H780RCI OpticsPUMP HOUSE112003H7802022-12-05
G358121002H780RCI OpticsREFUGE121002H7802022-12-05
G358121003H780RCI OpticsREFUGE121003H7802022-12-05
G358121005L25RCI OpticsREFUGE121005L252022-12-05
G358122003H780RCI OpticsREFUGE122003H7802022-12-05
G358131002H780RCI OpticsULUMAY131002H7802022-12-05
G358131003H780RCI OpticsULUMAY131003H7802022-12-05
G358132002H780RCI OpticsULUMAY132002H7802022-12-05
G358132003H780RCI OpticsULUMAY132003H7802022-12-05
G35881002H780RCI OpticsPOWER PLANT81002H7802022-12-05
G35881003H780RCI OpticsPOWER PLANT81003H7802022-12-05
G35881005L25RCI OpticsPOWER PLANT81005L252022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580822704165EYEVANEYEVAN INC.HQY2026-07-10
04580822704172EYEVANEYEVAN INC.HQY2026-07-10
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04580822704707EYEVANEYEVAN INC.HQY2026-07-10
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04580822705155EYEVANEYEVAN INC.HQY2026-07-10
04580822705162EYEVANEYEVAN INC.HQY2026-07-10
04580822705179EYEVANEYEVAN INC.HQY2026-07-10
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04580822705223EYEVANEYEVAN INC.HQY2026-07-10
04580822705230EYEVANEYEVAN INC.HQY2026-07-10
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04582669067892E5 eyevanEYEVAN INC.HQY2026-07-10
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04582669067915E5 eyevanEYEVAN INC.HQY2026-07-10
04582669067922E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068417E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068424E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068455E5 eyevanEYEVAN INC.HQY2026-07-10
04582669068462E5 eyevanEYEVAN INC.HQY2026-07-10
04582669069384EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069391EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069407EYEVAN7285EYEVAN INC.HQY2026-07-10
04582669069582EYEVAN7285EYEVAN INC.HQY2026-07-10