Microaire Surgical Instruments LLC

Address:3590 Grand Forks Blvd,CHARLOTTESVILLE,VA,22911,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, Scalpel (GES) (8) Rasp (HTR) (2)

Premarket Exempt

No Yes

Clear

MicroAire® - 00847399000958 Catalog Number :

Device Description : SMALL SAGITTAL SAW BLADE, 10.2mm X 18.3mm X 0.5mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399000965 Catalog Number :

Device Description : SMALL SAGITTAL SAW BLADE, 6.9mm X 28.7mm X 0.5mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399000989 Catalog Number :

Device Description : MICRO SAGITTAL SAW BLADE, 9.4mm X 25.5mm X 0.5mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399000996 Catalog Number :

Device Description : SMALL RECIP. SAW BLADE, 8mm x 25.4mm x 0.7mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399001016 Catalog Number :

Device Description : SMALL RECIP. SAW BLADE, 4.3mm X 12.7mm X 0.9mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399001023 Catalog Number :

Device Description : SMALL RECIP. SAW BLADE, 4.3mm X 12.7mm X 0.9mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399001030 Catalog Number :

Device Description : SMALL RECIP. SAW BLADE, 5mm X 22.9mm X 0.6mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399001047 Catalog Number :

Device Description : SMALL RECIP. SAW BLADE, 9mm x 40mm x 0.8mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399001054 Catalog Number :

Device Description : RASP, CROSS CUT TEAR, 5.3mm x 11mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : HTR

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399001061 Catalog Number :

Device Description : RASP, STRAIGHT COTTLE, 5.6mm X 15.5mm

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : HTR

Prescription Use : Yes

Device Count : 1

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