OPTICAL INTEGRITY INC

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

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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

Powered laser surgical instrument (GEX) (10)

Premarket Exempt

No Yes

Clear

Calculase Laser Fiber - B14527750365U1C0 Catalog Number :

Device Description : 365 micrometer Calculase Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B14527750550U10 Catalog Number :

Device Description : 550 micrometer ScopeSafe laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Calculase Laser Fiber - B14527750550U1C0 Catalog Number :

Device Description : 550 micrometer Calculase Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B14527750940U10 Catalog Number :

Device Description : 940 micrometer ScopeSafe laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Calculase Laser Fiber - B14527750940U1C0 Catalog Number :

Device Description : 940 micrometer Calculase Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B145P00120200SS0 Catalog Number :

Device Description : 200 micrometer ScopeSafe laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B145P00120272SS0 Catalog Number :

Device Description : 272 micrometer ScopeSafe laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber reusable - B145P00120272SSR0 Catalog Number :

Device Description : 272 micrometer ScopeSafe laser fiber reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B145P00120300SS0 Catalog Number :

Device Description : 300 micrometer ScopeSafe laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B145P00120300SSR0 Catalog Number :

Device Description : 300 micrometer ScopeSafe laser fiber reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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