FLUOREX®300

GUDID B316FLX3000

Rigid-gas-permeable corrective contact lens, daily wear

G. T. LABORATORIES, INC.

Rigid-gas-permeable corrective contact lens, daily-wear

• Primary Device ID: B316FLX3000
• NIH Device Record Key: 2aaf7b1b-29b8-44d0-9398-b77f5fa874e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUOREX®300
• Version Model Number: FLX300
• Company DUNS: 039634472
• Company Name: G. T. LABORATORIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-321-4060
• Email: info@gtlabs.us
• Phone: 800-321-4060
• Email: info@gtlabs.us

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B316FLX3000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P880001

FDA Product Code

• HQD: Lens, Contact (Other Material) - Daily

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B316FLX3000]

Liquid Chemical

[B316FLX3000]

Liquid Chemical

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-07-17
• Device Publish Date: 2017-09-20

Devices Manufactured by G. T. LABORATORIES, INC.

• B316FLX3000 - FLUOREX®300: 2018-07-17Rigid-gas-permeable corrective contact lens, daily wear
• B316FLX3000 - FLUOREX®300: 2018-07-17 Rigid-gas-permeable corrective contact lens, daily wear
• B316FLX300UV0 - FLUOREX®300UV: 2018-07-17 Ridgid-gas-permeable corrective contact lens, daily ware
• B316FLX5000 - FLUOREX®500: 2018-07-17 Ridgid-gas-permeable corrective contact lens, daily ware
• B316FLX500UV0 - FLUOREX®500UV: 2018-07-17 Ridgid-gas-permeable corrective contact lens, daily wear
• B316FLX7000 - FLUOREX®700: 2018-07-17 Ridgid-gas-permeable corrective contact lens, daily wear
• B316FLX700UV0 - FLUOREX®700UV: 2018-07-17 Ridgid-gas-permeable corrective contact lens, daily wear