BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Various Models ATS with LOP Sensor

    Reg #: 1526350 · FEI: 1526350 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ZIMMER SURGICAL, INC.
    Registration Number
    1526350
    FEI Number
    1526350
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    200 WEST OHIO AVE.
    City
    Dover
    State
    OH
    ZIP
    44622
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050411

    Owner / Operator

    Firm Name
    ZIMMER, INC.
    Operator Number
    1822565
    Address
    345 E. Main Street, --
    City
    Warsaw
    State
    IN
    Postal Code
    46580
    Country
    US

    Products

    Device Name Product Code
    Tourniquet, Pneumatic KCY

    Proprietary Names

    Various Models ATS with LOP Sensor Hoses Single Port/Dual Bladder Disposable Cuff Single Port/Dual Bladder Disposable Cuff with PLC Dual Port, Single Bladder cuff with PLC and protective sleeve Tank Holder Luer Adaptors ATS Cylindrical Cuff, Dual Port/Single Bladder Dual Port/Single Bladder Contour Lge Thigh Cuff ATS Cyclindrical Cuff, Single Port/Dual Bladder Stand Base Basket ATS Cylindrical Cuff, Dual Port/Dual Bladder Retrofit Kit Dual Port/Dual Bladder Disposable Cuff Single Port/Single Bladder Contour Lge Thigh Cuff Single Port, Single Bladder cuff with PLC and protective sleeve ATS3000 Tourniquet System Protective sleeve for Disposable Cuff ATS Cylindrical Cuff, Single Port/Single Bladder Single Port/Single Bladder Disposable Cuff Dual Port, Dual Bladder, cuff with PLC and protective sleeve Dual Port/Single Bladder Disposable Cuff

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device