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

272 ScopeSafe Laser Fiber - 00810077630013 Catalog Number : 10211

Device Description : 272 ScopeSafe Laser Fiber, Single Use

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

300 ScopeSafe Laser Fiber - 00810077630020 Catalog Number : 10212

Device Description : 300 ScopeSafe Laser Fiber, Single Use

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

200 ScopeSafe Laser Fiber - 00810077630037 Catalog Number : 10236

Device Description : 200 ScopeSafe Laser Fiber, Single Use

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

365 ScopeSafe Laser Fiber - 00810077630044 Catalog Number : 10237

Device Description : 365 ScopeSafe Laser Fiber, Single Use

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

550 ScopeSafe Laser Fiber - 00810077630051 Catalog Number : 10238

Device Description : 550 ScopeSafe Laser Fiber, Single Use

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

1000 ScopeSafe Laser Fiber - 00810077630068 Catalog Number : 10239

Device Description : 1000 ScopeSafe Laser Fiber, Single Use

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

272 ScopeSafe Laser Fiber - 00810077630075 Catalog Number : 10240

Device Description : 272 ScopeSafe Laser Fiber, Reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

200µm ScopeSafe Laser Fiber - 00810077630082 Catalog Number : 10366

Device Description : 200µm ScopeSafe Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

272 ScopeSafe Laser Fiber - 00810077630099 Catalog Number : 10367

Device Description : 272 ScopeSafe Laser Fiber

Device Class :

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

365 Laser Fiber - 00810077630105 Catalog Number : 10368

Device Description : 365 Laser Fiber

Device Class :

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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