FLUOREX®700

Basic Information

• Brand Name: FLUOREX®700
• Primary DI: B316FLX7000
• Version / Model: FLX700
• Company Name: G. T. LABORATORIES, INC.
• Labeler DUNS: 039634472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-20
• Public Version: 5
• Public Version Date: 2018-07-17
• Public Version Status: Update
• Public Device Record Key: ec488ffa-34f7-4943-8009-0e9900e93e78

Device Description

Ridgid-gas-permeable corrective contact lens, daily wear

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQD	Lens, Contact (Other Material) - Daily	Ophthalmic	886.5916	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47840	Rigid-gas-permeable corrective contact lens, daily-wear	A rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. The lens may last for years and is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B316FLX7000	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P880001	028