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

Osteotome, Manual (GFI) (8) Cutter, Surgical (FZT) (1) Screwdriver (HXX) (1)

Premarket Exempt

Yes

Clear

Tecomet - 00841435109117 Catalog Number :

Device Description : HOKE OSTEOTOME STRAIGHT 5 1/4", 5/8" 16MM

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109124 Catalog Number :

Device Description : LAMBOTTE OSTEOTOME STRAIGHT 7" 12MM

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109131 Catalog Number :

Device Description : LAMBOTTE OSTEOTOME 9" STRAIGHT 1/2"

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109148 Catalog Number :

Device Description : LAMBOTTE OSTEOTOME 9" CURVED 1/2"

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109155 Catalog Number :

Device Description : HOKE CHISEL 7" STRAIGHT 16MM

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109162 Catalog Number :

Device Description : LAMBOTTE OSTEOTOME 7" STRAIGHT 16MM

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109179 Catalog Number :

Device Description : LAMBOTTE OSTEOTOME 9" CURVED 3/4"

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Tecomet - 00841435109186 Catalog Number :

Device Description : LAMBOTTE OSTEOTOME 9"

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : GFI

Prescription Use : Yes

Device Count : 1

Table Top Rod Cutter 4.5 - 5.0 - 5.5 - 6.0 - 00841435109575 Catalog Number :

Device Description : Table Top Rod Cutter

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Bio-Modular/Comprehensive Instrument - 00841435109629 Catalog Number : TR225001-A

Device Description : Bio-Modular/Comprehensive Instrument Ratcheting T-Handle

Device Class : 1

Duns Number: 078749695

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

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