FDA.report

RCI Optics

Primary DI
G35841002H780
Brand
RCI Optics
Company
RCI Optics
Model
SPANISH HOUSE
Catalog number
41002H780
Device description
MATTE BLACK GREY ATLANTIC BLUE MIRROR H780
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HQYSunglasses (Non-Prescription Including Photosensitive)

Product Code Classifications

CodeDeviceSpecialtyClass
HQYSunglasses (Non-Prescription Including Photosensitive)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G35841002H780PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
065413366
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
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
G358122002H780RCI OpticsREFUGE122002H7802022-12-05
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

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