BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Medium

    Reg #: 2183744 · FEI: 2183744 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2183744
    FEI Number
    2183744
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    380 90TH AVE NW
    City
    Minneapolis
    State
    MN
    ZIP
    55433
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203459

    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
    Catheter, Septostomy DXF
    Introducer, Catheter DYB

    Proprietary Names

    EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Medium EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Large EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer (TSP/I) System - Small EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer (TSP/I) System - Large EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer (TSP/I) System - Medium EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - X-Small EastEnd10482 (MN) - SafeCross Transseptal Puncture and Introducer Short Access System (TSP/ISA) - Small

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)