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

Camera, Surgical And Accessories (KQM) (4) Lamps, Microscope (KEG) (1) Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

No Yes

Clear

Accu-Beam - B177LEDTCCW0 Catalog Number :

Device Description : Topcon LED Illumination upgrade. Continuous wave only.

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : KEG

Prescription Use : No

Device Count : 1

Accu-Beam - B177SA10597510 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for lasers.Straight/Rigid - 24cm, 14ga, ID 1.5mm.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B177ST656180 Catalog Number :

Device Description : LED Pen Light with Clip and removable diffuser.

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

Accu-Beam - B177TTI4KR0 Catalog Number :

Device Description : Single chip video camera with recorder and wireless functionality.2160p 60hz, HDMI output.

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

Accu-Beam - B177TTIHD0 Catalog Number :

Device Description : Single chip video camera without recorder.1080p 60hz, HDMI output.

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

Accu-Beam - B177TTIHDR0 Catalog Number :

Device Description : Single chip video camera with recorder.1080p 60hz, HDMI output.

Device Class : 1

Duns Number: 130213366

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

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