Flexlens

Basic Information

• Brand Name: Flexlens
• Primary DI: 00847835000016
• Version / Model: Sphere
• Company Name: X-Cel Specialty Contacts
• Labeler DUNS: 048610864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-22
• Public Version: 1
• Public Version Date: 2026-01-30
• Public Version Status: New
• Public Device Record Key: 84083e03-2cd7-4a30-b9d8-fc319b941925

Device Description

Flexlens Sphere

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	886.5925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47842	Soft corrective contact lens, daily-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 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10847835000013	GS1	Carton	3	In Commercial Distribution
Primary	00847835000016	GS1
Package	20847835000010	GS1	Carton	6	In Commercial Distribution