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

365 Laser Fiber with Resister Sleeve - 00810077630211 Catalog Number : 10627

Device Description : 365 Laser Fiber with Resister Sleeve

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

550 Laser Fiber with Resistive Sleeve - 00810077630228 Catalog Number : 10628

Device Description : 550 Laser Fiber with Resistive Sleeve

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

365 Laser Fiber Extended Length (4m) - 00810077630235 Catalog Number : 10674

Device Description : 365 Laser Fiber Extended Length (4m)

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

272 ScopeSafe Laser Fiber, Reusable - 00810077630242 Catalog Number : 10728

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

365 Laser Fiber, Reusable - 00810077630259 Catalog Number : 10739

Device Description : 365 Laser Fiber, Reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

550 Laser Fiber, Reusable - 00810077630266 Catalog Number : 10741

Device Description : 550 Laser Fiber, Reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

300 ScopeSafe Laser Fiber - 00810077630273 Catalog Number : 10902

Device Description : 300 ScopeSafe Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

200 Flex-G Laser Fiber with Extended Length Sheath - 00810077630280 Catalog Number : 10906

Device Description : 200 Flex-G Laser Fiber with Extended Length Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

272 Flex-G Laser Fiber with Extended Length Sheath - 00810077630297 Catalog Number : 10910

Device Description : 272 Flex-G Laser Fiber with Extended Length Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

300 Flex-G Laser Fiber with Extended Length Sheath - 00810077630303 Catalog Number : 10914

Device Description : 300 Flex-G Laser Fiber with Extended Length Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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