BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    StealthStation

    DI: 00763000238889 · Model: 9735744 · MEDTRONIC NAVIGATION, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    StealthStation
    Primary DI
    00763000238889
    Version / Model
    9735744
    Company Name
    MEDTRONIC NAVIGATION, INC.
    Labeler DUNS
    835233107
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-27
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    54a11766-1f36-4bec-a3f7-0684d8f18f71

    Device Description

    SW KIT 9735744 S8 STEALTHLINK

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HAW Neurological stereotaxic Instrument
    PGW Ear, Nose, and Throat Stereotaxic Instrument
    OLO Orthopedic stereotaxic instrument

    GMDN Terms

    Code Name
    45199 Multi-purpose stereotactic surgery system

    Identifiers

    Type ID
    Primary 00763000238889

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K162309 000