FreshKon® 1-Day (Etafilcon A)

Basic Information

• Brand Name: FreshKon® 1-Day (Etafilcon A)
• Primary DI: 08886428047368
• Version / Model: Alluring Eye,Mosaic,Colors Fusion
• Company Name: OCULUS PRIVATE LIMITED
• Labeler DUNS: 936888460
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5594f883-21f9-4c3d-b417-a3cc63037fd0

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVN	Lens, Contact, (Disposable)	Ophthalmic	886.5925	2
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	886.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47841	Soft corrective contact lens, daily-disposable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08886428047368	GS1
Unit of Use	08886428047733	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Outer Diameter	14.20	Millimeter