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

Arthroscope (HRX) (3) Blade, Scalpel (GES) (3) Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment (HSZ) (2) Knife, Surgical (EMF) (2) System, Suction, Lipoplasty For Removal (QPB) (2) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

MicroAire® - 00847399016836 Catalog Number :

Device Description : WIDE SAW BLADE LINVATEC STYLE

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016843 Catalog Number :

Device Description : NARROW SAW BLADE LINVATEC STYLE

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016850 Catalog Number :

Device Description : PNEUMATIC MOTOR MODULE, MICROAIRE CONNECTOR

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : HSZ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016867 Catalog Number :

Device Description : PNEUMATIC MOTOR MODULE, HALL STYLE CONNECTOR

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : HSZ

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016874 Catalog Number :

Device Class : 2

Duns Number: 103056420

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016898 Catalog Number :

Device Class : 2

Duns Number: 103056420

Premarket Exempt : No

Product Code : QPB

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016928 Catalog Number :

Device Description : Instrument Sterilization Tray, SmartRelease

Device Class : 2

Duns Number: 103056420

Premarket Exempt : No

Product Code : HRX, KCT

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016935 Catalog Number :

Device Description : Dilator - Small, SmartRelease

Device Class : 1

Duns Number: 103056420

Premarket Exempt : No

Product Code : HRX, EMF

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016942 Catalog Number :

Device Description : Dilator - Medium, SmartRelease

Device Class : 1

Duns Number: 103056420

Premarket Exempt : No

Product Code : HRX, EMF

Prescription Use : Yes

Device Count : 1

MicroAire® - 00847399016966 Catalog Number :

Device Description : RECIPROCATING DOUBLE SIDED BLADE

Device Class : 1

Duns Number: 103056420

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

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