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

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment (KIJ) (5) Motor, Surgical Instrument, Pneumatic Powered (GET) (5) Blade, Scalpel (GES) (3) Arthroscope (HRX) (2) Knife, Surgical (EMF) (2)

Premarket Exempt

No Yes

Clear

MicroAire® - 00847399016034 Catalog Number :

Device Description : Co-Equal to Standard Blade, SmartRelease

Device Class : 1

Duns Number: 103056420

Premarket Exempt : No

Product Code : HRX, EMF

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016041 Catalog Number :

Device Description : Co-Equal to Onyx Blade, SmartRelease

Device Class : 1

Duns Number: 103056420

Premarket Exempt : No

Product Code : EMF, HRX

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016065 Catalog Number :

Device Description : High Speed Drill Coupler

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GET, KIJ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016072 Catalog Number :

Device Description : Bur Guard, Medium

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GET, KIJ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016089 Catalog Number :

Device Description : Bur Guard, Long

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GET, KIJ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016102 Catalog Number :

Device Description : 5130 Spare Parts Kit

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GET, KIJ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016119 Catalog Number :

Device Description : Cleaning Brush

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GET, KIJ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016805 Catalog Number :

Device Description : RAYHACK(R) SAW BLADE ULNAR & KIENBOCK'S

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016812 Catalog Number :

Device Description : RAYHACK(R) SAW BLADE RADIAL DISTRACTION

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016829 Catalog Number :

Device Description : RAYHACK(R) SAW BLADE ULNAR & KIENBOCK'S

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

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