TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Address:220 Porter Drive,SAN RAMON,CA,94583,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

No Yes

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Accu-Beam - B17710597390 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers.40cm, 14 gauge, rigid, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597400 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers.40cm, 14 gauge, 15 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597420 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.190mm, 35 degree bend, spatula tip, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597450 Catalog Number :

Device Description : Robotic Flexible Guide

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597500 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.230mm, 35 degree bend, spatula tip, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597510 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 230mm with spatula tip, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597610 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.60mm, Straight/rigid, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597700 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.130mm, 35 degree bend, spatula tip, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597800 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 5cm, 0 degree Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 5cm, 0 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597810 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 5cm, 25 degre Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 5cm, 25 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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