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) (7) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

No Yes

Clear

MasterPulse laser fiber 550 Round tip - B145118050 Catalog Number :

Device Description : MasterPulse laser fiber 550 micrometers, Round Tip

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MasterPulse laser fiber 1000 micrometer - B145118090 Catalog Number :

Device Description : MasterPulse laser fiber, 1000 micrometers, round tip

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MasterPulse 200 TRUE laser fiber - B14511822 Catalog Number :

Device Description : MasterPulse 200 micron TRUE laser fiber, single use, sterile

Device Class : 2

Duns Number: 024050887

Premarket Exempt : Yes

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B14527750200U10 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

Calculase Laser Fiber - B14527750200U1C0 Catalog Number :

Device Description : 200 micrometer Calculase Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FlexGuard Fiber with Sheath Calculase compatible - B14527750200U1CFS0 Catalog Number :

Device Description : 200 micrometer FlexGuard Fiber with Sheath Calculase compatible

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FlexGuard Fiber with Sheath - B14527750200U1FS0 Catalog Number :

Device Description : 200 micrometer FlexGuard Fiber with Sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FlexGuard Laser Fiber with Extended Length Sheath - B14527750200U1SH0 Catalog Number :

Device Description : 200 micrometer FlexGuard fiber with extended length sheath

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ScopeSafe™Laser Fiber - B14527750272U10 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

Calculase Laser Fiber - B14527750272U1C0 Catalog Number :

Device Description : 272 micrometer Calculase Laser Fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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