OMNIGUIDE, INC.

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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

Clear

Handpiece Tray for AccuBeam Otology - 00894338002351 Catalog Number : OTO-TRAY

Device Description : Handpiece Tray for Otology

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BeamPath NEURO-L Fiber - 00894338002672 Catalog Number : NEURO-L

Device Description : Laser Fiber

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FELS Laser System - 00894338002726 Catalog Number : FELS-25A

Device Description : FELS Laser System

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Elevate™ENT Handpiece 15cm 25°-S - 00894338002740 Catalog Number : 321004

Device Description : Elevate™ENT Handpiece

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Elevate™ENT Handpiece 17cm 45°/0° -S - 00894338002771 Catalog Number : 321005

Device Description : Elevate™ENT Handpiece

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BeamPath ROBOTIC fiber - 00894338002818 Catalog Number : ROBOTIC

Device Description : Laser Fiber

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Elevate™ ENT Elite Fiber - 00894338002825 Catalog Number : 322001

Device Description : Laser Fiber

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Omniguide Select Fiber - 00894338002849 Catalog Number : 322003

Device Description : Laser Fiber

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Velocity™ High Performance Fiber - 00894338002856 Catalog Number : 332005

Device Description : Laser Fiber

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Lapflex, Laparoscopic Articulating Handpiece- 33cm - 00894338002863 Catalog Number : 341001

Device Description : Lapflex Handpiece

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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