BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HALYARD® ONE-STEP® Sterilization Wrap

    Reg #: 1054380 · FEI: 1000110722 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Halyard North Carolina, LLC
    Registration Number
    1054380
    FEI Number
    1000110722
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    389 CLYDE FITZGERALD RD
    City
    LINWOOD
    State
    NC
    ZIP
    27299
    Country
    US

    Regulatory Submissions

    510(k) Number
    K234050

    Owner / Operator

    Firm Name
    O&M Halyard, Inc.
    Operator Number
    10057479
    Address
    1220 Old Alpharetta Rd, Suite 320
    City
    Alpharetta
    State
    GA
    Postal Code
    30005
    Country
    US
    Correspondent
    Angela Bunn

    Products

    Device Name Product Code
    Wrap, Sterilization FRG

    Proprietary Names

    HALYARD® ONE-STEP® Sterilization Wrap HALYARD® SEQUENTIAL Sterilization Wrap HALYARD® SMART-FOLD® Sterilization Wrap HALYARD® QUICK CHECK® Sterilization Wrap

    Establishment Types

    Manufacture Medical Device