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 IDB316FLX3000
NIH Device Record Key2aaf7b1b-29b8-44d0-9398-b77f5fa874e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLUOREX®300
Version Model NumberFLX300
Company DUNS039634472
Company NameG. T. LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-321-4060
Emailinfo@gtlabs.us
Phone800-321-4060
Emailinfo@gtlabs.us

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB316FLX3000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQDLens, Contact (Other Material) - Daily

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B316FLX3000]

Liquid Chemical


[B316FLX3000]

Liquid Chemical


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-07-17
Device Publish Date2017-09-20

Devices Manufactured by G. T. LABORATORIES, INC.

B316FLX3000 - FLUOREX®3002018-07-17Rigid-gas-permeable corrective contact lens, daily wear
B316FLX3000 - FLUOREX®3002018-07-17 Rigid-gas-permeable corrective contact lens, daily wear
B316FLX300UV0 - FLUOREX®300UV2018-07-17 Ridgid-gas-permeable corrective contact lens, daily ware
B316FLX5000 - FLUOREX®5002018-07-17 Ridgid-gas-permeable corrective contact lens, daily ware
B316FLX500UV0 - FLUOREX®500UV2018-07-17 Ridgid-gas-permeable corrective contact lens, daily wear
B316FLX7000 - FLUOREX®7002018-07-17 Ridgid-gas-permeable corrective contact lens, daily wear
B316FLX700UV0 - FLUOREX®700UV2018-07-17 Ridgid-gas-permeable corrective contact lens, daily wear

Trademark Results [FLUOREX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLUOREX
FLUOREX
97842115 not registered Live/Pending
Akzo Nobel Coatings International B.V.
2023-03-16
FLUOREX
FLUOREX
75361700 2178655 Live/Registered
AKZO NOBEL COATINGS INC.
1997-09-20
FLUOREX
FLUOREX
74254590 1805202 Dead/Cancelled
KABUSHIKI KAISHA TOSHIBA
1992-03-12
FLUOREX
FLUOREX
74232810 1758078 Dead/Cancelled
GT LABORATORIES, INC.
1991-12-23
FLUOREX
FLUOREX
73768847 1554682 Live/Registered
REXHAM CORPORATION
1988-12-12

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