FDA.report

Comfort Colors

Primary DI
08809959695129
Brand
Comfort Colors
Company
INTEROJO INC.
Model
True Sapphire / -04.75
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications

CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08101405709634PrimaryGS10
08809959695129Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08101405709634081014057096348101405709634
08809959695129088099596951298809959695129

GMDN Terms

TermDefinition
Soft corrective contact lens, daily-wearA soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1-954-401-5604rho@interojo.com
+1-954-401-5604wayne@tuscanyeyewear.com

Regulatory Flags

DUNS number
688455799
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
08809752409763HAPA KRISTINOn Vacation Kristin Blue Trial /-00.00 2025-04-18
08809752409770HAPA KRISTINSoft Haze Kristin Hazel Trial /-00.00 2025-04-18
08809752409787HAPA KRISTINPlayful Kristin Blue Trial /-00.00 2025-04-18
08809752409794HAPA KRISTINPlayful Kristin Gray Trial /-00.00 2025-04-18
08800245547405MizMiz/Aqua2024-09-24
08800245547412MizMiz/Dark Gray2024-09-24
08800245547429MizMiz/Trinity Gray2024-09-24
08800245547436MizMiz/Mint Green2024-09-24
08800245547443MizMiz/Honey2024-09-24
08800245547450MizMiz/Jade2024-09-24
08800245547467MizMiz/Angel Violet2024-09-24
08800245547474MizMiz/Sunset Brown 2024-09-24
08800245547481MizMiz/Fiesta Gray2024-09-24
08800245547498MizMiz/Chestnut Brown2024-09-24
08800245547504MizMiz/Marble Gray2024-09-24
08800245547511MizMiz/Twilight Hazel2024-09-24
08800245547528MizMiz/Serenity Brown2024-09-24
08800245547535MizMiz/Angel Gray2024-09-24
08800245547542MizMiz/Honey Hazel2024-09-24
08800245547559MizMiz/Topaz Hazel2024-09-24

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08800071419549Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
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08800071419570Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11
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08800071419594Another Me Kristin MonthlyDK MEDIVISION Co.,Ltd.LPL2026-02-11