BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERRAD NX and 100NX with DTI Connectivity (DTINX, DTI100NX)

    Reg #: 2084725 · FEI: 3003662624 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    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
    K151725

    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
    Sterilizer, Chemical MLR

    Proprietary Names

    STERRAD NX and 100NX with DTI Connectivity (DTINX, DTI100NX)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device