BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TYVEK Pouch/Roll with STERRAD Chemical Indicator

    Reg #: 1418005 · FEI: 3003243311 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    AMCOR FLEXIBLES, LLC
    Registration Number
    1418005
    FEI Number
    3003243311
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1919 S Butterfield Rd
    City
    MUNDELEIN
    State
    IL
    ZIP
    60060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K951295

    Owner / Operator

    Firm Name
    Amcor Flexibles
    Operator Number
    9059465
    Address
    1919 South Butterfield Rd.
    City
    Mundelein
    State
    IL
    Postal Code
    60060
    Country
    US
    Correspondent
    Brian - Foley

    Products

    Device Name Product Code
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    TYVEK Pouch/Roll with STERRAD Chemical Indicator

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device