TECOMET INC.

Address:115 Eames Street,Wilmington,MA,01887,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

Bit, Drill (HTW) (5) Extractor (HWB) (3) Instrument, Bending Or Contouring (HXP) (1) Screwdriver (HXX) (1)

Premarket Exempt

Yes

Clear

Tecomet - 00818069013936 Catalog Number :

Device Description : Driver Assembly, Hexalobe Male T27 1/4" Male Square Drive

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014087 Catalog Number :

Device Description : Driver Assembly, Hexalobe Male T15 1/4" Male Square Drive

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014117 Catalog Number :

Device Description : PLATE BENDING IRON

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HXP

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014148 Catalog Number :

Device Description : TORQUE-LIMITING AXIAL MINI CUSTOM TRI FLAT BLUE

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014209 Catalog Number :

Device Description : Cervive Driver-Zimmer Spine

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014216 Catalog Number :

Device Description : Driver Assembly, Spinelink

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014223 Catalog Number :

Device Description : Driver Assembly, Hex Female 1/2" 1/4" Male Square Drive

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014230 Catalog Number :

Device Description : Reamer Assembly, Hollow 8mm 1/4" Male Square Drive

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014247 Catalog Number :

Device Description : Trephine Screw Remover 3.5mm

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

Tecomet - 00818069014254 Catalog Number :

Device Description : Trephine Screw Remover 4.0mm

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HWB

Prescription Use : Yes

Device Count : 1

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