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) (10)

Premarket Exempt

Yes

Clear

N/A - 00817438027338 Catalog Number :

Device Description : 3.0 MM X 2.35 MM X 48.0 MM ROUND OSTEON CARBIDE BUR, 8 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027345 Catalog Number :

Device Description : 5.0 MM X 2.35 MM X 38.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027352 Catalog Number :

Device Description : 4.0 MM X 2.35 MM X 38.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027369 Catalog Number :

Device Description : 2.4 MM X 2.35 MM X 48.0 MM ROUND OSTEON CARBIDE BUR, 8 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027376 Catalog Number :

Device Description : 5.0 MM X 2.35 MM X 48.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027383 Catalog Number :

Device Description : 4.0 MM X 2.35 MM X 48.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027390 Catalog Number :

Device Description : 1.0 MM X 2.35 MM X 48.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027406 Catalog Number :

Device Description : 3.0 MM X 2.35 MM X 48.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027413 Catalog Number :

Device Description : 0.7 MM X 2.35 MM X 48.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027420 Catalog Number :

Device Description : 0.5 MM X 2.35 MM X 48.0 MM ROUND OSTEON DIAMOND STAINLESS STEEL BUR

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

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