WISDOM MEDICAL TECHNOLOGY, LLC

Address:7791 Aqua Circle, Suite 7G,Dalton Gardens,ID,83815,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) (10)

Premarket Exempt

Clear

Twister - 00859337007103 Catalog Number : 101258-IC

Device Description : lateral emitting laser fiber

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007110 Catalog Number : ENT-20-US-IC

Device Description : MegaBeam® Single Use, Handpiece

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007127 Catalog Number : 101095-IC

Device Description : end emitting laser fiber, single use, 600 micron flat tip

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007134 Catalog Number : 101095-SF IC

Device Description : end emitting laser fiber, single use, 600 micron, SF

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Twister L - 00859337007141 Catalog Number : 101220-SMA

Device Description : lateral emitting laser fiber

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007158 Catalog Number : 101260-IC

Device Description : lateral emitting laser fiber, single use, 600 micron radial tip

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007165 Catalog Number : 101255-IC

Device Description : lateral emitting laser fiber, single use, 400 micron, radial tip

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Twister - 00869851000306 Catalog Number : 101175

Device Description : lateral emitting laser fiber

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Twister L - 00869851000313 Catalog Number : 101220

Device Description : lateral emitting laser fiber

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Twister XL - 00869851000320 Catalog Number : 101300

Device Description : lateral emitting laser fiber

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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