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 - B17710597820 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 7cm, 25 degre Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 7cm, 25 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597830 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 14cm, 21 degr Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 14cm, 21 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597840 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 15cm, 25 degr Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 15cm, 25 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597850 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 17cm, 45 degr Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 17cm, 45 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597860 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 17cm, 45 & 15 Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 17cm, 45 & 15 degree bends.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597870 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 17cm, 45 & 30 Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 17cm, 45 & 30 degree bends.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597880 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 22cm, 45 & 30 Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 22cm, 45 & 30 degree bends. Spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597890 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 22cm, 45 & 15 Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 22cm, 45 & 15 degree bends. Spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597900 Catalog Number :

Device Description : Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 22cm, 45 degr Re-usable weighted fiberoptic handpiece for lasers. Blue.14 gauge, 22cm, 45 degree bend, spatula tip.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Accu-Beam - B17710597910 Catalog Number :

Device Description : Re-usable fiberoptic handpiece for CO2 lasers.60mm, 15 degree bend, spatula tip, blue.

Device Class : 2

Duns Number: 130213366

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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