FreshKon® 1-Day (Etafilcon A)

Primary DI
08886428047368
Brand
FreshKon® 1-Day (Etafilcon A)
Company
OCULUS PRIVATE LIMITED
Model
Alluring Eye,Mosaic,Colors Fusion
Device description
10 sterile one day disposable daily wear soft contact lenses, 42% etafilcon A, 58% water, immersed in 0.9% buffered saline.Indication for Use:The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPLLenses, Soft Contact, Daily Wear
MVNLens, Contact, (Disposable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPLLenses, Soft Contact, Daily WearOphthalmic2
MVNLens, Contact, (Disposable)Ophthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886428047368PrimaryGS10
08886428047733Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886428047368088864280473688886428047368
08886428047733088864280477338886428047733

GMDN Terms#

Term, Definition table
TermDefinition
Soft corrective contact lens, daily-disposableA 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 (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter14.2Millimeter

Contacts#

Phone, Email table
PhoneEmail
18558290813singapore@oculuslens.com

Regulatory Flags#

DUNS number
936888460
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886428047375FreshKon® 1-Day (Etafilcon A)Alluring Eye, Colors Fusion,Mosaic2016-09-15
08886428047382FreshKon® (Methafilcon A) Alluring Eye, Mosaic,Colors Fusion2016-09-15

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