BEUDAMED
    FDA Registration Active 🇺🇸 United States

    AccessSci5463 (TM) - POWERWAND XL 5Fr x 10cm, Introducer with Extended Dwell Catheter

    Reg #: 2030624 · FEI: 3000206435 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Isomedix Operations, Inc.
    Registration Number
    2030624
    FEI Number
    3000206435
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43425 Business Park Dr
    City
    Temecula
    State
    CA
    ZIP
    92590
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131300

    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
    Introducer, Catheter DYB

    Proprietary Names

    AccessSci5463 (TM) - POWERWAND XL 5Fr x 10cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND 4FRr x 8cm, Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND 4Fr X 10cm, Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 5Fr X 10cm, Introducer with Extended Dwell Catheter w Bifurcated Extension Set AccessSci5463 (TM) -POWERWAND XL 4Fr X 10cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND 5Fr x 8cm Safety Introducer with Extended Dwell Catheter AccessSci5463 (TM) - Pouch, PW XL, 4FR, 10CM, CE AccessSci5463 (TM) - POWERWAND XL 5Fr x 8cm Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL, 4Fr x 8cm Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 4Fr X 8cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND AL-REC 4Fr x 6cm, Introducer with Extended Dwell Catheter AccessSci5463 (TM) - POWERWAND XL 5Fr x 8cm Extended Dwell Catherter AccessSci5463 (TM) - POWERWAND 5Fr x 10cm Safety Introducer with Extended Dwell Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)