FDA.reportPublic FDA data

Comfort Colors

Primary DI
08101270298424
Brand
Comfort Colors
Company
New York Optical-International, Inc.
Model
Gray / -00.00
Published
2023-08-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08101270298424PrimaryGS10
08809959694702Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08101270298424081012702984248101270298424
08809959694702088099596947028809959694702

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1-954-401-5604wayne@tuscanyeyewear.com

Regulatory Flags#

DUNS number
969551498
Device count
6
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08101270298356Comfort ColorsHoney / -00.00 2023-08-10
08101270298592Comfort ColorsGreen / -00.00 2023-08-10
08101270298660Comfort ColorsHazel / -00.00 2023-08-10
08101270298738Comfort ColorsBrown / -00.00 2023-08-09
08101270298806Comfort ColorsTrue Sapphire / -00.00 2023-08-10
08101270298974Comfort ColorsHoney / -00.50 2023-08-10
08101270299032Comfort ColorsGray / -00.50 2023-08-09
08101270299100Comfort ColorsGreen / -00.50 2023-08-10
08101270299278Comfort ColorsHazel / -00.50 2023-08-10
08101270299346Comfort ColorsBrown / -00.50 2023-08-09
08101270299414Comfort ColorsTrue Sapphire / -00.50 2023-08-10
08101270299582Comfort ColorsHoney / -00.75 2023-08-10
08101270299650Comfort ColorsGray / -00.75 2023-08-09
08101270299728Comfort ColorsGreen / -00.75 2023-08-10
08101270299896Comfort ColorsHazel / -00.75 2023-08-10
08101270299964Comfort ColorsBrown / -00.75 2023-08-09
08101405700006Comfort ColorsTrue Sapphire / -00.75 2023-08-10
08101405700174Comfort ColorsHoney / -01.00 2023-08-10
08101405700242Comfort ColorsGray / -01.00 2023-08-09
08101405700310Comfort ColorsGreen / -01.00 2023-08-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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