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

NEURO Handpiece, 6cm, Bent - 00852306007104 Catalog Number : NEURO-HP-6B

Device Description : Handpiece, NEURO, Mark III, 6cm Bayonet

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NEURO Handpiece, 8cm, Bent - 00852306007111 Catalog Number : NEURO-HP-8B

Device Description : Handpiece, NEURO, Mark III, 8cm Bayonet

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NEURO Handpiece, 8cm, Straight - 00852306007128 Catalog Number : NEURO-HP-8

Device Description : Handpiece, NEURO, Mark III, 8cm, Straight

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NEURO Handpiece, 10cm, Bent - 00852306007135 Catalog Number : NEURO-HP-10B

Device Description : Handpiece, NEURO, Mark III, 10cm, Bayonet

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN Handpiece, 46 cm, Straight - 00852306007142 Catalog Number : GYN-HP-46

Device Description : Handpiece, GYN, Mark III, 46 cm, Straight with Strain Relief

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN-LAP Handpiece, 33cm, Bent - 00852306007159 Catalog Number : GYN-LAP-33B

Device Description : Handpiece, Fixed Bend, Laparoscopic, 33 cm X 5 mm

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN-Laparoscopic Handpiece, 29 cm, Straight - 00852306007166 Catalog Number : GYN-HP-29

Device Description : Handpiece, GYN, Mark III, 29 cm, Straight w/ Strain Relief

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN Handpiece Mark III, 6 cm - 00852306007173 Catalog Number : GYN-HP-6

Device Description : Handpiece, GYN, Mark III, 6 cm, Straight

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN Handpiece, 3.5 cm, Straight - 00852306007180 Catalog Number : GYN-HP-3.5

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

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

GYN Handpiece Mark III, 6 cm Bent - 00852306007197 Catalog Number : GYN-HP-6B

Device Description : Handpiece, GYN, Mark III, 6 cm, Single Bend

Device Class : 2

Duns Number: 030124221

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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