G. T. LABORATORIES, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Lens, Contact (Other Material) - Daily (HQD) (6)

Premarket Exempt

Clear

FLUOREX®300 - B316FLX3000 Catalog Number :

Device Description : Rigid-gas-permeable corrective contact lens, daily wear

Device Class : 2

Duns Number: 039634472

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

FLUOREX®300UV - B316FLX300UV0 Catalog Number :

Device Description : Ridgid-gas-permeable corrective contact lens, daily ware

Device Class : 2

Duns Number: 039634472

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

FLUOREX®500 - B316FLX5000 Catalog Number :

Device Description : Ridgid-gas-permeable corrective contact lens, daily ware

Device Class : 2

Duns Number: 039634472

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

FLUOREX®500UV - B316FLX500UV0 Catalog Number :

Device Description : Ridgid-gas-permeable corrective contact lens, daily wear

Device Class : 2

Duns Number: 039634472

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

FLUOREX®700 - B316FLX7000 Catalog Number :

Device Description : Ridgid-gas-permeable corrective contact lens, daily wear

Device Class : 2

Duns Number: 039634472

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

FLUOREX®700UV - B316FLX700UV0 Catalog Number :

Device Description : Ridgid-gas-permeable corrective contact lens, daily wear

Device Class : 2

Duns Number: 039634472

Premarket Exempt : No

Product Code : HQD

Prescription Use : Yes

Device Count : 1

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