BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow® DuoFlex® Spring-Wire Guide

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1061124
    FEI Number
    1000512168
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10821 Withers Cove Park Dr
    City
    Charlotte
    State
    NC
    ZIP
    28278
    Country
    US

    Regulatory Submissions

    510(k) Number
    K810675

    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
    Wire, Guide, Catheter DQX

    Proprietary Names

    Arrow® DuoFlex® Spring-Wire Guide Arrow® Arterial Line Kit Arrow® Radial Artery Catheterization Set Arrow® Spring-Wire Guide Arrow® Arterial Catheterization Kit Arrow Select Kits Arrow® Femoral Artery Catheterization Set Arrow® Arterial/Venous Catheterization Set Arrow® Positive Placement Spring-Wire Guide Arrow® Arterial Catheterization Set Arrow® Femoral Arterial Line Catheterization Kit Arrow® Radial Artery Catheterization Kit Arrow® QuickFlash® Radial Artery Catheterization Kit Arrow® Marked Spring-Wire Guide with Arrow Advancer¿ Arrow® Transradial Artery Access Kit

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)