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) (10)

Premarket Exempt

Yes

Clear

N/A - 00817438020209 Catalog Number :

Device Description : 60.0 MM X 19.3 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

N/A - 00817438020216 Catalog Number :

Device Description : 85.0 MM X 24.9 MM X 1.32 MM SAGITTAL BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020223 Catalog Number :

Device Description : 90.0 MM X 15.0 MM X 1.31 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020230 Catalog Number :

Device Description : 85.0 MM X 25.4 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 - 00817438020247 Catalog Number :

Device Description : 26.0 MM X 0.52 MM RECIPROCATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020254 Catalog Number :

Device Description : 85.0 MM X 25.4 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 - 00817438020261 Catalog Number :

Device Description : 90.0 MM X 13.0 MM X 1.23 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020278 Catalog Number :

Device Description : 90.0 MM X 19.0 MM X 1.27 MM OSCILLATING BLADE

Device Class : 1

Duns Number: 808825038

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

N/A - 00817438020285 Catalog Number :

Device Description : 90.0 MM X 23.0 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 - 00817438020292 Catalog Number :

Device Description : 70.0 MM X 31.0 MM X 0.89 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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