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

300 Flex-G Laser Fiber with Sheath - 00810077630419 Catalog Number : 11111

Device Description : 300 Flex-G Laser Fiber with Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

200 ScopeSafe Laser Fiber with ScopeGuardian Sheath - 00810077630426 Catalog Number : 11141

Device Description : 200 ScopeSafe Laser Fiber with ScopeGuardian Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

272 ScopeSafe Laser Fiber with ScopeGuardian Sheath - 00810077630433 Catalog Number : 11143

Device Description : 272 ScopeSafe Laser Fiber with ScopeGuardian Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

300 ScopeSafe Laser Fiber with ScopeGuardian Sheath - 00810077630440 Catalog Number : 11145

Device Description : 300 ScopeSafe Laser Fiber with ScopeGuardian Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

200 ScopeSafe Laser Fiber - 00810077630457 Catalog Number : 11211

Device Description : 200 ScopeSafe Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

1000 Laser Fiber - 00810077630464 Catalog Number : 11213

Device Description : 1000 Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

QLASE Side Fire Laser Fiber with Adjustable Stand-Off Catheter - 00810077630471 Catalog Number : 11505

Device Description : QLASE Side Fire Laser Fiber with Adjustable Stand-Off Catheter

Device Class :

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

QLASE Adjustable Stand-Off Catheter - 00810077630488 Catalog Number : 11515

Device Description : QLASE Adjustable Stand-Off Catheter

Device Class :

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

272 ScopeSafe Laser Fiber with Soft Tip - 00810077630495 Catalog Number : 11521

Device Description : 272 ScopeSafe Laser Fiber with Soft Tip

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

200 ScopeSafe Laser Fiber with Soft Tip - 00810077630501 Catalog Number : 11531

Device Description : 200 ScopeSafe Laser Fiber with Soft Tip

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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