OPTICAL INTEGRITY INC

Address:19408 Panama City Beach Pkwy,P C Beach,FL,32413,US

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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

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

No Yes

Clear

SU-550 - B145117470 Catalog Number :

Device Description : 550 micrometer laser fiber, single use, sterile

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SU-1000 - B145117510 Catalog Number :

Device Description : 1000 micrometer laser fiber, single use, sterile

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Smart Scope 272 Micrometer Reusable Laser fiber - B145117680 Catalog Number : 11768

Device Description : Smart Scope 272 micrometer laser fiber, round tip, reusable, sterile

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Smart Scope 365 micrometer laser fiber, reusable, sterile - B145117720 Catalog Number :

Device Description : Smart Scope 365 micrometer laser fiber, reusable, sterile

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SmartScope 550 micron fiber, reusable - B145117760 Catalog Number :

Device Description : SmartScope 550 micron fiber, flat tip, reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Smart Scope 1000 micrometer reusable laser fiber - B145117800 Catalog Number : 11780

Device Description : Smart Scope 1000 micrometer reusable laser fiber, packaged sterile

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Excalibur MasterPulse Laser Fiber, 200-TRUE - B145117850 Catalog Number :

Device Description : ForTec Excalibur MasterPulse True 200 micrometer laser fiber

Device Class :

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Excalibur MasterPulse 200 - B145117930 Catalog Number :

Device Description : Excalibur MasterPulse Laser Fiber, 200 Micrometer

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MASTERPULSE LASER FIBER 272 MICROMETER - B145117970 Catalog Number :

Device Description : MasrerPulse laser fiber 272 micrometer

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MasterPulse Round Tip 365 - B145118010 Catalog Number :

Device Description : MasterPulse Round tip laser fiber, 365 micrometer

Device Class :

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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