OPTICAL INTEGRITY INC

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

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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) (6)

Premarket Exempt

No Yes

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Optical Integrity Laser Fiber - B145P001203650 Catalog Number :

Device Description : 365 micrometer laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Optical Integrity Laser Fiber - B145P00120365R0 Catalog Number :

Device Description : 365 micrometer laser fiber reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Optical Integrity Laser Fiber - B145P001205500 Catalog Number :

Device Description : 550 micrometer laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Optical Integrity Laser Fiber - B145P00120550R0 Catalog Number :

Device Description : 550 micrometer laser fiber reusable

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Optical Integrity Laser Fiber - B145P001210000 Catalog Number :

Device Description : 1000 micrometer laser fiber

Device Class : 2

Duns Number: 024050887

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Optical Integrity Laser Fiber - B145P00121000R0 Catalog Number :

Device Description : 1000 micrometer 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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