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    FDA Registration Active 🇺🇸 United States

    StrykerPR3324 (VG) - Acm system with restrictor

    Reg #: 1424263 · FEI: 3003015552 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    1424263
    FEI Number
    3003015552
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2500 Commerce Dr
    City
    Libertyville
    State
    IL
    ZIP
    60048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K931847

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    1527821
    Address
    5960 Heisley Rd, --
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Cement Obturator LZN

    Proprietary Names

    StrykerPR3324 (VG) - Acm system with restrictor StrykerPR3324 (LS) - Bioprep Cement Restrictor StrykerPR3324 (GR) - ACM W/Nozzle/Restrictor/Press. 6 pkg.

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)