TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

Address:220 Porter Drive,SAN RAMON,CA,94583,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) (7) Tray, Surgical, Instrument (FSM) (3)

Premarket Exempt

No Yes

Clear

Accu-Beam - B1770960870 Catalog Number :

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

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1770960880 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.240mm, 35 degree bend, 30.7mm radi Re-usable fiberoptic handpiece for CO2 lasers.240mm, 35 degree bend, 30.7mm radius tip, DBI bend.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1770960890 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.290mm, straight/rigid, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1770961280 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 190mm, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1770961290 Catalog Number :

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

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1770966060 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers.400mm, double bend at handle & tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056521G0 Catalog Number :

Device Description : Fiber Handpiece GYN Sterilization Tray

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056521H0 Catalog Number :

Device Description : Weighted Handpiece Tray

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056521M0 Catalog Number :

Device Description : Malleable HP Sterilization Tray

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056521MKIT0 Catalog Number :

Device Description : Kit of 4 malleable fiber handpieces and sterilization tray. Included UDIs are:+B Kit of 4 malleable fiber handpieces and sterilization tray. Included UDIs are:+B177AC90MMM0+B177AC140MMM0+B177AC240MMM0+B177AC300MMM0+B1771056521M0

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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