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

Blade, Saw, General & Plastic Surgery, Surgical (GFA) (8) Bur, Surgical, General & Plastic Surgery (GFF) (2)

Premarket Exempt

Yes

Clear

N/A - 00817438020100 Catalog Number :

Device Description : 6,0 MM X 2.35 MM X 70.0 MM ACORN STAINLESS STEEL BUR, 8 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438020117 Catalog Number :

Device Description : 6.0 MM X 2.35 MM X 70.0 MM ACORN STAINLESS STEEL BUR W/J-NOTCH, 8 FLUTE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438020124 Catalog Number :

Device Description : 50.0 MM X 24.0 MM X 1.03 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020131 Catalog Number :

Device Description : 50.0 MM X 18.0 MM X 1.02 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020148 Catalog Number :

Device Description : 50.0 MM X 12.0 MM X 1.02 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020155 Catalog Number :

Device Description : 63.5 MM X 0.89 MM SEGMENTED ROUND OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020162 Catalog Number :

Device Description : 90.0 MM X 19.0 MM X 1.37 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020179 Catalog Number :

Device Description : 90.0 MM X 25.4 MM X 1.33 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020186 Catalog Number :

Device Description : 90.0 MM X 25.4 MM X 1.26 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020193 Catalog Number :

Device Description : 60.0 MM X 12.7 MM X 0.97 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

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