BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Arrow® NextStep® Hemodialysis Catheter Long-Term Access

    Reg #: 1061124 · FEI: 1000512168 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    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
    K111117

    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
    Catheter, Hemodialysis, Implanted MSD

    Proprietary Names

    Arrow® NextStep® Hemodialysis Catheter Long-Term Access Arrow® NextStep® Retrograde Replacement Hub Set Arrow® Cannon® II Plus Replacement Hub Set Arrow® Edge® Hemodialysis Catheterization Set, Long-Term Access Arrow® NextStep® Antegrade Hemodialysis Catheterization Set, Long-Term Access Arrow® NextStep® Antegrade / Simplicity¿ Hemodialysis Catheterization Set, Long-Term Access Arrow® NextStep® Retograde Hemodialysis Catheterization Set with Arrow® Simplicity¿ Long-Term Access Arrow® Cannon® II Plus/Simplicity¿ Hemodialysis Catheterization Kit, Long-Term Access Arrow® NextStep® Retograde Hemodialysis Catheter Long-Term Access Arrow® NextStep® Antegrade/Simplicity¿ Hemodialysis Catheterization Set Long-Term Access Arrow® Cannon® II Plus Long-Term Access Arrow® NextStep® Antegrade Hemodialysis Catheter, Long-Term Access Arrow® Edge®/Simplicity¿ Hemodialysis Catheterization Set, Long-Term Access Arrow® Edge® Hemodialysis Catherization Set Long-Term Access Arrow Select Kits Arrow® Edge® Hemodialysis CatheterizationSet, Long-Term Access Arrow® Edge® Hemodialysis Catheter, Long-Term Access Arrow® Edge® Hemodialysis Catherization Set, Long-Term Access Arrow® Cannon® II Plus Hemodialysis Catheterization Set, Long-Term Access

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)