BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stainless Steel Angiography Guide Wires

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    1054811
    FEI Number
    1000114185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    502 Prairie Mine Rd
    City
    MULBERRY
    State
    FL
    ZIP
    33860
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113584

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Transducer, Pressure, Catheter Tip DXO
    Wire, Guide, Catheter DQX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG

    Proprietary Names

    Stainless Steel Angiography Guide Wires Bard Stainless Steel Guide Wires Safety Spring (SOS) Guide Wires Archer Superstiff Guide Wire InQwire Guide Wire Angiography Guide Wires (non-Teflon coated) Bard PTFE Coated Guide Wires & Bard PTFE Coated Guide Wire w/BH Coating PTFE Coated Angiography Guide Wires PTFE Coated Angiography Guide Wires with BH Coating AngioAssist Family Bard PTFE Coated Guide Wire w/BH Coating CERTUS 300 AERIS AERIS 300 RECEIVER PressureWire Aeris PressureWire Certus

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)