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

NA - 00817438027673 Catalog Number :

Device Description : 40.0 MM X 11.1 MM X 0.58 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438027680 Catalog Number :

Device Description : 95.0 MM X 1.09 MM RECIPROCATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

NA - 00817438027697 Catalog Number :

Device Description : 2.1 MM X 2.35 MM X 60.0 MM TAPERED SIDE CUTTING CARBIDE BUR WITH O NOTCH, 6 FLUT 2.1 MM X 2.35 MM X 60.0 MM TAPERED SIDE CUTTING CARBIDE BUR WITH O NOTCH, 6 FLUTE NON STERILE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 00817438027703 Catalog Number :

Device Description : 50.0 MM X 9.0 MM X 1.00 MM OSCILLATING BLADE NON STERILE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

NA - 00817438027710 Catalog Number :

Device Description : 50.0 MM X 9.0 MM X 1.00 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

NA - 00817438027727 Catalog Number :

Device Description : 38.0 MM x 9.7 MM x 0.64 MM Sagittal Blade - Non Sterile

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438027734 Catalog Number :

Device Description : 2.3 MM X 2.35 MM X 60.0 MM RND CARBIDE BUR 8 FLT O NCH

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

N/A - 00817438027758 Catalog Number :

Device Description : 29.5 MM x 7.0 MM X 0.43 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438027765 Catalog Number :

Device Description : 40.0 MM X 6.0 MM X 0.61 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438027772 Catalog Number :

Device Description : 40.0 MM X 6.0 MM X 0.61 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

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