TRIMEDYNE, INC.

Address:519 N. Smith Avenue, Suite 105,Corona,CA,92878,US

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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) (3)

Premarket Exempt

Clear

Trimedyne® FlexMax® 550 µm Single Use Holmium Fiber - M473S5500 Catalog Number : S550

Device Description : Fiber, Bare, 550um, Single Use, TMED Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® FlexMax® 550 µm Single Use Fiber (SMA Connector) - M473S550SMA0 Catalog Number : S550SMA

Device Description : Fiber, Bare, 550um, Single Use, SMA Connector

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

100 Watt Holmium Side Fire Fiber - M473SF6000 Catalog Number : SF-600

Device Description : 100 Watt Holmium Side Fire Fiber

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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