TRIMEDYNE, INC.

Address:519 N. Smith Avenue, Suite 105,Corona,CA,92878,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) (8) Needle, Conduction, Anesthetic (W/Wo Introducer) (BSP) (1) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

Clear

Trimedyne® Gas-Cooled 600 µm Fiber with Nozzle Tip (SMA Connector) - M473205030 Catalog Number : 20503

Device Description : Gas-Cooled Fiber, Nd:YAG

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® R-50™ Spinal Introduction Cannula - M473700520 Catalog Number : 70052

Device Description : Introducer, Spine, 1.75mm ID

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : BSP

Prescription Use : Yes

Device Count : 1

Trimedyne® Omni™ Sterilization Tray System - M47372050 Catalog Number : 7205

Device Description : Omni Sterilization Tray System

Device Class : 1

Duns Number: 057007239

Premarket Exempt : No

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Trimedyne® 550 µm Test Laser Fiberoptic - M4737600 Catalog Number : 760

Device Description : Test Fiber, 550um, Holmium

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber - M473B2000 Catalog Number : B200

Device Description : Fiber, Bare, 200um, Reusable, TMED Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 200 µm Reusable Holmium Bare Fiber, 5m Length - M473B2005M0 Catalog Number : B200-5M

Device Description : Fiber, Bare, 200um, Reusable, TMED Connector, 5m long

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 200 µm Reusable Fiber (SMA Connector), 5m Length - M473B2005MSMA0 Catalog Number : B2005M-SMA

Device Description : Fiber, Bare, 200um, Reusable, SMA Connector, 5m long

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 200 µm Reusable Fiber (SMA Connector) - M473B200SMA0 Catalog Number : B200SMA

Device Description : Fiber, Bare, 200um, Reusable, SMA Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 272 µm Reusable Holmium Bare Fiber - M473B2720 Catalog Number : B272

Device Description : Fiber, Bare, 272um, Reusable, TMED Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 272 µm Reusable Fiber (SMA Connector) - M473B272SMA0 Catalog Number : B272SMA

Device Description : Fiber, Bare, 272um, Reusable, SMA Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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