WISDOM MEDICAL TECHNOLOGY, LLC

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

No

Clear

FLA - 00859337007004 Catalog Number : 10102B

Device Description : lateral emitting shaped laser fiber, single use

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

FLA - 00859337007011 Catalog Number : 10102B-IC

Device Description : lateral emitting shaped laser fiber, single use

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Twister XXL - 00859337007028 Catalog Number : 101315-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

Twister - 00859337007035 Catalog Number : 101175-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

Twister XL - 00859337007042 Catalog Number : 101300-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 - 00859337007059 Catalog Number : AP-400-15

Device Description : MegaBeam® Single Use, End Emitting, Handpiece 15 Deg.

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007066 Catalog Number : 101256

Device Description : MegaBeam 400um SMA, radial emitting laser fiber, single use

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007073 Catalog Number : AP-400-30

Device Description : MegaBeam® Single Use, End Emitting, Handpiece 30 Deg.

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007080 Catalog Number : 101257

Device Description : Twister 600um SMA, side firing laser fiber, single use

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MegaBeam - 00859337007097 Catalog Number : 101257-IC

Device Description : MegaBeam® 400um, Radial Tip, Side Firing laser fiber, single use

Device Class : 2

Duns Number: 080537625

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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