IDEAL SiHy/1Month/6PK

Basic Information

• Brand Name: IDEAL SiHy/1Month/6PK
• Primary DI: 00840486901718
• Version / Model: 9G14
• Company Name: VIZIONFOCUS INC.
• Labeler DUNS: 658860374
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-12
• Public Version: 1
• Public Version Date: 2026-02-20
• Public Version Status: New
• Public Device Record Key: a85a74ef-06a8-42b7-a479-accd10f50684

Device Description

SiHy/UV/56T/PWR: -2.25

Device Characteristics

• Single Use: No
• 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: Yes
• 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
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	886.5925	2
MVN	Lens, Contact, (Disposable)	Ophthalmic	886.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47843	Soft corrective contact lens, extended-wear	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 for continuous overnight wear ranging from 6 to 30 consecutive nights. 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 highly permits diffusion of oxygen (O2) to the ocular surface. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840486901718	GS1

Premarket Submissions

Submission Number	Supplement Number
K251573	000