Omega Surgical Instruments Inc

Address:1072 S. Elms Road,Flint,MI,48532,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

Bur, Surgical, General & Plastic Surgery (GFF) (9) Bit, Drill (HTW) (1)

Premarket Exempt

Yes

Clear

N/A - 00817438027536 Catalog Number :

Device Description : 2.0 MM X 2.35 MM X 30.0 MM ROUND OSTEON STAINLESS STEEL BUR, 6 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027543 Catalog Number :

Device Description : 2.5 MM X 2.35 MM X 30.0 MM ROUND OSTEON STAINLESS STEEL BUR, 6 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027550 Catalog Number :

Device Description : 4.0 MM X 2.35 MM X 30.0 MM ROUND OSTEON DERMABRADER DIAMOND BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027567 Catalog Number :

Device Description : 7.0 MM X 2.35 MM X 30.0 MM ROUND OSTEON DERMABRADER DIAMOND BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027574 Catalog Number :

Device Description : 12.0 MM X 2.35 MM X 30.0 MM ROUND OSTEON DERMABRADER DIAMOND BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027581 Catalog Number :

Device Description : 10.0 MM X 2.35 MM X 30.0 MM ROUND OSTEON DERMABRADER DIAMOND BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027598 Catalog Number :

Device Description : 1.0 MM X 2.35 MM X 38.0 MM WIREPASS OSTEON SS BUR, 2 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027604 Catalog Number :

Device Description : 1.5 MM X 2.35 MM X 38.0 MM WIREPASS OSTEON SS BUR, 2 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027611 Catalog Number :

Device Description : 2.0 MM X 2.35 MM X 38.0 MM WIREPASS OSTEON SS BUR, 2 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027659 Catalog Number :

Device Description : 2.5 MM X 170.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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