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) (8) Tray, Surgical, Instrument (FSM) (2)

Premarket Exempt

No Yes

Clear

Accu-Beam - B1771056521R0 Catalog Number :

Device Description : Rigid HP Sterilization Tray

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056521RKIT0 Catalog Number :

Device Description : Kit of 8 ENT fiber handpieces and sterilization tray. Included UDIs are:+B177920 Kit of 8 ENT fiber handpieces and sterilization tray. Included UDIs are:+B17792020+B17792030+B17792040+B17792050+B17792060+B17792070+B17792080+B17792090+B1771056521R0

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056522G0 Catalog Number :

Device Description : Fiber Handpiece GYN Sterilization Tray. Long handle.

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : No

Device Count : 1

Accu-Beam - B1771056522GKIT0 Catalog Number :

Device Description : Kit of 3 GYN fiber handpieces and sterilization tray. Included UDIs are:+B177918 Kit of 3 GYN fiber handpieces and sterilization tray. Included UDIs are:+B17791851BS0+B1779185-1S0+B1779185-2BS0+B1771056522G0

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597110 Catalog Number :

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

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597120 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers. 190mm/163.1 with 35 degree bend. 30.7 Re-usable fiberoptic handpiece for lasers. 190mm/163.1 with 35 degree bend. 30.7R at tip. Blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597210 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, Blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597230 Catalog Number :

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

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597300 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers. 130mm/129.4 with 15 degree bend & spa Re-usable fiberoptic handpiece for lasers. 130mm/129.4 with 15 degree bend & spatula, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597380 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers.14 gauge, 340mm, 20 degree bend.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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