BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SmartAblateTM System Irrigation Pump

    DI: 04260166371093 · Model: M490008 · Stockert GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SmartAblateTM System Irrigation Pump
    Primary DI
    04260166371093
    Version / Model
    M490008
    Company Name
    Stockert GmbH
    Labeler DUNS
    327536314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    adb5849f-6848-4b19-8fa4-93f213144eaf

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LPB Cardiac Ablation Percutaneous Catheter

    GMDN Terms

    Code Name
    41643 Surgical irrigation/aspiration system pump

    Identifiers

    Type ID
    Primary 04260166371093