BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NextPhase Medical Devices LLC

    Reg #: 1225492 · FEI: 3001237338 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    18

    Registration Details

    Registration Name
    NextPhase Medical Devices LLC
    Registration Number
    1225492
    FEI Number
    3001237338
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    88 Airport Dr
    City
    ROCHESTER
    State
    NH
    ZIP
    03867
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103767

    Owner / Operator

    Firm Name
    NextPhase Medical Devices LLC
    Operator Number
    9026654
    Address
    88 AIRPORT DR.
    City
    Rochester
    State
    NH
    Postal Code
    03867
    Country
    US
    Correspondent
    James G Bennett

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Mouthpiece, Breathing BYP
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Neurological Stereotaxic Instrument HAW
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Semi-Automated Autologous Skin Graft Harvesting And Application Device QYK
    Culture, Intravaginal, Assisted Reproduction OYO
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Orthopedic Stereotaxic Instrument OLO
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days LJS
    Ear, Nose, And Throat Stereotaxic Instrument PGW
    Ventilator, Continuous, Facility Use CBK
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Continuous, Ventilator, Home Use NOU

    Proprietary Names

    23-314-1 BIPOLAR SEALER AQM MINI EVS3.4 23-121-1 BIPOLAR SEALER AQM EVS 23-113-1 BIPOLAR SEALER AQM 2.3 23-312-1 BIPOLAR SEALER AQM SBS 5 BITE BLOK AEVUMED PHANTOM™-LP SUTURE ANCHORS BIT 9733518 3.5MM Drill Sterile Patient Tracker 9734887 Non-Invasive Patient Tracker 9735300 Skull Mount PKGD Shunt Kit 9733605 Non-Invasive Shunt Kit 9733606 Skull Mounted 9733606-G02 Patient Tracker 9734887XOM Non-Invasive BIT 9733517 3MM Drill Sterile Stylet 9735428 2 Coil Single Package BIT 9733519 3MM Cannulated Sterile Shunt Kit 9733606 Skull Mounted Philips Fisher & Paykel RT265 Circuit (1141548) Philips Fisher & Paykel 900MR810 Circuit (1141549) Aquamantys 6 Bipolar Sealer AEVUMED RAPID SUTURE ANCHORS ART CARTRIDGE KIT 23-321-1 AQM MIS FLEX 23-322-1 AQM MIS FLEX MINI AxiEM Philips Fisher & Paykel RT211 Circuit (1141427) AEVUMED PHANTOM SUTURE ANCHORS INVOcell STALIF C STALIF C-Ti MIDLINE II MIDLINE II-Ti STALIF MIDLINE PAK 9733498NAV NAVIGATED PEDICLE ACCESS Kit PAK 9733497NAV NAV NIM-SPINE PEDICLE ACCESS KIT Pak 9733497 NAV NIM-SPINE PEDICLE ACC KIT PAK 9733498 NAVIGATED PEDICLE ACCESS KIT SMARTPICC ACCESSORY PACK Suction 9735019 Malleable STD TIP 12-FR Suction 9735015 Malleable STD Tip 7-FR Suction 9735018 Malleable Ball Tip 9-FR Suction 9735017 Malleable Angle Tip 9-FR Suction 9735016 Malleable STDTIP 9-FR Malleable Bipolar Sealer with Light Philips Disp External Flow Sensor, Pediatric/Infant, 10/PK (1146558) Philips Disp External Flow Sensor, Adult/Pediatric, 10/PK (1147497) Philips Dual LimAEV Single PK (1132110) Philips Dual LimAEV10/PK (1139436) Philips External Flow Sensor Cable (1134592) Philips Trilogy EV300, External Flow Sensor Assembly with Cable, Adult/Pediatric (1132106) STALIF L Philips F1O2 Sensor Assembly STALIF L FLX STALIF C FLX ACTILIF C FLX STALIF M FLX Stealth AXiS™ Stealthstation Philips Fisher & Paykel RT385 Circuit (1144701) Philips Dual LimAEV 10/PK (1139436) 23-317-1 BIPOLAR SEALER AQM ENDO DBS 8.7 23-320-1 BIPOLAR SEALER AQM ENDO VS8.7R VATS Tumor Resection Kit 9733607 Non-Invasive Bit 9733515 2.4mm Drill Sterile Bit 9733516 2.9mm Drill Sterile Pointer 9733424 Touch-N-Go Axiem 5pk Tumor Resection Kit 9733608 Skull Mount Pointer 9733423 Tracer Axiem 5PK

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device