BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Pivot International

    Reg #: 1000655158 · FEI: 1000655158 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    6

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    Registration Details

    Registration Name
    Pivot International
    Registration Number
    1000655158
    FEI Number
    1000655158
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    11030 Strang Line Rd
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US

    Owner / Operator

    Firm Name
    Pivot International Inc
    Operator Number
    10043496
    Address
    11030 Strang Line Rd.
    City
    Lenexa
    State
    KS
    Postal Code
    66215
    Country
    US

    Products

    Device Name Product Code
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    System, Suction, Lipoplasty For Removal QPB
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Motor, Surgical Instrument, Ac-Powered GEY
    Operating Room Accessories Table Tray FWZ
    Platform, Force-Measuring KHX

    Proprietary Names

    BioWave GO Rx ASP-PUMP-120, PAL Aspiration Pump, 115V ASP-PUMP-240, PAL Aspiration Pump, 230V ASP-UI, PAL Aspiration Pump Console WalterLorenz Surgical Assist Arm Zibrio Pro; Zibrio SmartScale Platform, Force-Measuring

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Develop Specifications But Do Not Manufacture At This Facility