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) (10)

Premarket Exempt

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Trimedyne® OmniTip™ Switchable Tip - 20° - M47320475HP0 Catalog Number : 20475-HP

Device Description : Tip, Switchable, Omni HP System, 20 degree

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® Reposable OmniTip™ Switchable Tip - 20° - M47320475MHP0 Catalog Number : 20475M-HP

Device Description : Multiuse Switchable Tip, Omni HP System, 20 degree

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Switchable Tip - 30° - M47320476HP0 Catalog Number : 20476-HP

Device Description : Tip, Switchable, Omni HP System, 30 degree

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® Reposable OmniTip™ Switchable Tip - 30° - M47320476MHP0 Catalog Number : 20476M-HP

Device Description : Multiuse Switchable Tip, Omni HP System, 30 degree

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Switchable Tip - 60° - M47320478HP0 Catalog Number : 20478-HP

Device Description : Tip, Switchable, Omni HP System, 60 degree

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Switchable Tip - Side Firing - M47320479HP0 Catalog Number : 20479-HP

Device Description : Ho:YAG OmniTip HP System, Sidefire, 12.5 cm

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Mini Side Firing (90°) Switchable Tip - M47320489HP0 Catalog Number : 20489-HP

Device Description : Ho:YAG OmniTip HP System, Sidefire, 6.5 cm

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Straight - M47320495HP0 Catalog Number : 20495-HP

Device Description : Tip, Switchable, 0 degree, SJ-90

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Switchable Tip - SJ-90 mm Side Firing - M47320496HP0 Catalog Number : 20496-HP

Device Description : Tip, Switchable, Omni HP System, Sidefire, SJ-90

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Trimedyne® OmniTip™ Switchable Tip - SJ-50 mm Straight - M47320497HP0 Catalog Number : 20497-HP

Device Description : Tip, Switchable, 0 degree, SJ-50

Device Class : 2

Duns Number: 057007239

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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