BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX)

    Reg #: 2084725 · FEI: 3003662624 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    ADVANCED STERILIZATION PRODUCTS
    Registration Number
    2084725
    FEI Number
    3003662624
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    33 TECHNOLOGY DRIVE
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K163598

    Owner / Operator

    Firm Name
    Advanced Sterilization Products
    Operator Number
    9068155
    Address
    33 Technology Drive, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Brent Lewis

    Products

    Device Name Product Code
    Indicator, Physical/Chemical Sterilization Process JOJ
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility