BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MICROAIRE SURGICAL INSTRUMENTS LLC

    Reg #: 2020601 · FEI: 2020601 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    83
    Establishment Types
    4
    Classifications
    26

    Registration Details

    Registration Name
    MICROAIRE SURGICAL INSTRUMENTS LLC
    Registration Number
    2020601
    FEI Number
    2020601
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3590 Grand Forks Blvd
    City
    CHARLOTTESVILLE
    State
    VA
    ZIP
    22911
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060249

    Owner / Operator

    Firm Name
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Operator Number
    9004658
    Address
    3590 GRAND FORKS BOULEVARD, --
    City
    Charlottesville
    State
    VA
    Postal Code
    22911
    Country
    US
    Correspondent
    Chad Wade

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Screw, Fixation, Bone HWC
    Rasp, Surgical, General & Plastic Surgery GAC
    Knife, Surgical EMF
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Arthroscope HRX
    Orthopedic Manual Surgical Instrument LXH
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Stand, Infusion FOX
    Chisel (Osteotome) KDG
    Bit, Drill HTW
    Bur, Surgical, General & Plastic Surgery GFF
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Battery, Replacement, Rechargeable MOQ
    Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment KIJ
    Dissector, Surgical, General & Plastic Surgery GDI
    Pin, Fixation, Smooth HTY
    System, Suction, Lipoplasty For Removal QPB
    Accessories, Arthroscopic NBH
    Regulator, Pressure, Gas Cylinder CAN
    Lavage, Jet FQH
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Motor, Surgical Instrument, Pneumatic Powered GET
    System, Suction, Lipoplasty MUU
    Suture, Absorbable, Synthetic GAN
    Tubing, Pressure And Accessories BYX

    Proprietary Names

    ENDOTINE FOREHEAD INSTRUMENT KIT AND REPLACEMENT ASSEMBLIES ENDOTINE MIDFACE B INSTRUMENT KIT AND REPLACEMENT ASSEMBLIES Ultratine Forehead MicroAire Rasps SMARTRELEASE Endoscopic Soft Tissue Release System MICROAIRE MANUAL SURGICAL DRILL MicroAire Sterilization Cases (FROM PARAGON) Endotine Ribbon RAIL CLAMP POLE IV POLE BASKET CANISTER RING PAL CART PAL Sterilization Case MicroAire Chisels and Osteotomes Endotine Midface ST MicroAire Twist Drill MicroAire Burs MicroAire Cutters for Midas Rex Inst. 5025 Electric Instrument Console MicroAire Series 5000 Electric 5401 Electric Foot Pedal 5000 ET Electric Motor MicroAire SmartDriver Electric 5130 High Speed Drill Coupler MicroAire Series 7000 Electric Endotine Triple Endotine Forehead Mini MicroAire Batteries SMARTRELEASE® Endoscopic Soft Tissue Release System MicroAire 7000 Series Electric MicroAire SmartDriver Battery Various Couplers & Modules SURGIWIRE INCISIONLESS DISSECTOR MicroAire Kirschner Wires MicroAire Steinmann Pins 7020-PAL 7020-ASP 7020-PEDAL PAL 7020 Console 7020-INF PAL Multi-Use Infiltration Cannula PAL-INF-RXXXX Infiltration Foot Switch INF-FOOT-1 PAL Single-Use Infiltration Cannula PAL-INF-XXXX PAL Infiltration Pump INF-PUMP Infiltration Pump to 5020 Connection Cable INF-CBL-5020 PAL Infiltration Tubing PAL-INF-1600 Endotine Transbleph MicroAire SmartRelease System Accessories Endotine Forehead PAL Multi-use cannulas and PAL Manual Wand LipoTower PAL Tubing PAL-1200 PAL Console 5020 PAL Cable 5006-PAL PAL Handpiece PAL-650 PAL Disinfection CAP CAP-600E PAL Handpiece PAL-750 Nitrogen Regulators 9500-000, 9502-000 MicroAire Semi-Disposable Pulse Lavage ASP-CORD, AC Power Cord Jumper ASP-FOOT, Aspiration Foot Switch ASP-FLTR2, Biofilter 5020-ASP, 5020 to Aspiration Pump Cable ASP-UI, PAL Aspiration Pump Console ASP-TUBING, Vacuum Tubing, 4-Pk ASP-CBL, Aspiration Pump Cable ASP-PUMP-240, PAL Aspiration Pump, 230V ASP-PUMP-120, PAL Aspiration Pump, 115V MicroAire Cast Cutter Blades MicroAire Sternum Saw Blades MicroAire Sagittal Saw Blades MicroAire Oscillating Saw Blades MicroAire Reciprocating Saw Blades PAL Single-Use Cannulas MicroAire 5000 Series Pneumatic MicroAire 7000 Series Pneumatic MicroAire SmartDriver Pneumatic MicroAire 2500 Osteotome MicroAire SmartRelease System Endoscope (FROM HSW) LipoFilter LipoFilter NT Syringe Adapter, ASP-ADP-2 LipoFilter Stand, ASP-CAN-2R Endotine Midface B MicroAire 7000-Series Whisper Hoses Air Hose Connection Manifolds Air Hose Extensions MicroAire 9000-Series Air Hoses

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device