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

Clear

GYN Handpiece Mark III, 13 cm - 00852306007203 Catalog Number : GYN-HP-13

Device Description : Handpiece, GYN, Mark III, 13 cm, Straight

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN Handpiece Mark III, 13 cm Bent - 00852306007210 Catalog Number : GYN-HP-13B

Device Description : Handpiece, GYN, Mark III, 13 cm, Single Bend

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

OmniGuide® LapFlex Instrument Set - 00852306007227 Catalog Number : 341003

Device Description : LapFlex Instrumentation Set (1 HandPiece & 1 Tray)

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

OmniGuide® OmniFlex Instrument Set - 00852306007234 Catalog Number : 341004

Device Description : OmniFlex Instrumentation Set, LapFlex (1 Piece), FlexGuide Ultra (1 Piece) and Tray

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BeamPath GYN-LAP Handpiece Set - 00852306007241 Catalog Number : GYN-HS-LAP-1

Device Description : GYN Laparoscopic Handpiece Set, 2 Handpieces(GYN-LAP-33B and GYN-HP-46) & Tray(H GYN Laparoscopic Handpiece Set, 2 Handpieces(GYN-LAP-33B and GYN-HP-46) & Tray(Handpiece Tray, GYN, LAP)

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BeamPath GYN-LGT Handpiece Set - 00852306007258 Catalog Number : GYN-HS-LGT

Device Description : BeamPath GYN-LGT Handpiece Set, 5 Handpieces & Tray

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ELEVATE™ ENT Instrumentation Set - 13 - 00852306007265 Catalog Number : 321015

Device Description : ELEVATE™ ENT Instrumentation Set of 13 Elevate ENT Handpieces and 1 tray

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BeamPath NEURO Handpiece Set - 00852306007272 Catalog Number : NEURO-HS

Device Description : NEURO Handpiece Set, 6 Neuro Handpieces and Neuro Tray

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BeamPath OTO Handpiece Set - 00852306007289 Catalog Number : OTO-HS

Device Description : OTO Handpiece Set with 2 OTO Handpieces and OTO Tray

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

ELEVATE™ ENT Instrumentation Set - 11 - 00852306007296 Catalog Number : 321016

Device Description : ELEVATE™ ENT Instrumentation Set of 11 Elevate ENT Handpieces and 1 tray

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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