EnChroma®

Primary DI
00858545003884
Brand
EnChroma®
Company
Enchroma Inc.
Model
Ellis Tortoise Cx3 Outdoor Sun Lens
Device description
EnChroma lenses are 100% UVA/UVB/UVC blocking. EnChroma lenses are an optical assistive device only and are not a cure for color blindness. EnChroma lenses are designed for use with deuteranomalous or protanomalous color vision deficiency. The lens is not expected to assist with deuteranopia and protanopia. Effectiveness of the lens may vary depending on the type and extent of color vision deficiency. EnChroma lenses are not designed to defeat color blindness screening tests. EnChroma eyewear are not suitable for driving and road use. Tinted lenses may impair visibility in low light conditions and should not be used for driving in twilight, night, or through tunnels. When first trying on the lens, the unusual appearance of colors may be visually distracting. Always maintain awareness of potential hazards in your surroundings and take appropriate cautions when engaging in activities such as driving or operation of machinery. The lens is not certified for use in occupations where color blind individuals may be restricted for reasons of public safety, such as emergency first responders, and public transport operators. Store in a cool, dry area away from extreme temperatures as it can damage the lenses. DO NOT store the glasses inside hot vehicles.
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

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
00858545003884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858545003884008585450038848585450038840858545003884

GMDN Terms#

Term, Definition table
TermDefinition
Colour discrimination non-prescription spectaclesAn ophthalmic device consisting of a spectacle frame with a pair of coloured/tinted lenses (non-refractive) designed to be worn in front of the patient’s eyes to enhance colour discrimination in patients with colour vision deficiency; it is not intended to correct refractive vision conditions and is not customized for a specific patient.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.510.497.0048support@enchroma.com

Regulatory Flags#

DUNS number
963464198
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810750030031EnChroma®Ellis Grey Cx3 Outdoor Sun Lens2022-12-01
00810750030048EnChroma®Ellis Brown Cx3 Outdoor Sun Lens2022-12-01
00810750030062EnChroma®Ellis Brown Cx1 Indoor Lens 20182022-12-01
00810750030079EnChroma®Russell Black Cx2 Outdoor Shade Lens2022-12-01
00810750030116EnChroma®Solano Tortoise Cx3 Outdoor Sun Lens2022-12-01
00810750030123EnChroma®Gilman Black Cx3 Outdoor Sun Lens2022-12-01
00810750030130EnChroma®Twain Black Cx1 Indoor Lens 20182022-12-01
00810750030147EnChroma®Twain Night Sky Cx1 Indoor Lens 20182022-12-01
00810750030154EnChroma®Twain Black Cx3 Outdoor Sun Lens2022-12-01
00810750030161EnChroma®Twain Night Sky Cx3 Outdoor Sun Lens2022-12-01
00810750030185EnChroma®Panoramic XL Matte Black Cx3 Outdoor Sun Lens2022-12-01
00810750030192EnChroma®Ellis Brown Cx1 Indoor Lens2022-12-01
00810750030208EnChroma®Panoramic XL Matte Black Cx1 Indoor Lens2022-12-01
00810750030215EnChroma®Cx Series Professional Demo Kit - 3pc v.20222022-12-01
00810750030222EnChroma®Canyon Gunmetal Cx3 Outdoor Sun SP Lens2022-12-01
00810750030239EnChroma®Colby Black Cx3 Outdoor Sun SP Lens2022-12-01
00810750030246EnChroma®Derby Black Cx3 Outdoor Sun SP Lens2022-12-01
00810750030253EnChroma®Derby Black Cx1 Indoor Lens2022-12-01
00810750030277EnChroma®Derby Tortoise Cx3 Outdoor Sun SP Lens2022-12-01
00810750030284EnChroma®Ellis Black Cx3 Outdoor Sun SP Lens2022-12-01

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