OMNIGUIDE, INC.

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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) (10)

Premarket Exempt

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Elevate™ ENT Instrumentation Tray - 00852306007005 Catalog Number : 321014

Device Description : Elevate™ ENT Instrumentation Tray (13 Slot) to use with the elevate ENT handpieces

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

OmniGuide® LapFlex Tray - 00852306007012 Catalog Number : 341002

Device Description : LapFlex Instrumentation Tray to use with the Lapflex Handpiece.

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FLEXGUIDE-ULTRA Handpiece Tray - 00852306007029 Catalog Number : FLEX-TRAY

Device Description : Robotic Flexible Handpiece Tray, MediTray Aluminum Wide Mid Size Slim Case, 9.8" Robotic Flexible Handpiece Tray, MediTray Aluminum Wide Mid Size Slim Case, 9.8" x 8.1" x 0.8"

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NEURO Handpiece Tray - 00852306007036 Catalog Number : NEURO-TRAY

Device Description : Handpiece Tray for Neurology

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Core GYN Tray - 00852306007043 Catalog Number : 341005

Device Description : Handpiece Tray for Gynecology

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN Robotic Handpiece Tray - 00852306007050 Catalog Number : GYN-TRAY-MIS

Device Description : Handpiece Tray for GYN - Robotic

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN-LGT Handpiece Tray - 00852306007067 Catalog Number : GYN-TRAY-LGT

Device Description : Handpiece Tray for GYN Lower Genital Handpiece Set (GYN-HS-LGT)

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN-LAP Handpiece Tray - 00852306007074 Catalog Number : GYN-TRAY-LAP-1

Device Description : Handpiece Metal Tray for GYN Laparoscopic Handpieces

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NEURO Handpiece, 3.5cm, Straight - 00852306007081 Catalog Number : NEURO-HP-3.5

Device Description : Handpiece, NEURO, Mark III, 3.5cm, Straight

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NEURO Handpiece, 5cm, Straight - 00852306007098 Catalog Number : NEURO-HP-5

Device Description : Handpiece, NEURO, Mark III, 5cm, Straight

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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