BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Medistim QuickFIT TTFM probe

    DI: 07070554101006 · Model: PS101011 · Medistim ASA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Medistim QuickFIT TTFM probe
    Primary DI
    07070554101006
    Version / Model
    PS101011
    Catalog Number
    PS101011
    Company Name
    Medistim ASA
    Labeler DUNS
    519521751
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    5
    Public Version Date
    2021-04-07
    Public Version Status
    Update
    Public Device Record Key
    198e70e2-1b9a-428d-964d-0c08fa330eb7

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Liquid Chemical", "Hydrogen Peroxide", "Ethylene Oxide"]

    Product Codes

    Code Name
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    61226 Invasive vascular ultrasound system probe

    Identifiers

    Type ID
    Primary 07070554101006

    Premarket Submissions

    Submission Number Supplement Number
    K992305 000