BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR8 Stealth-Midas

    DI: 00763000063337 · Model: EM800N-R · MEDTRONIC PS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MR8 Stealth-Midas
    Primary DI
    00763000063337
    Version / Model
    EM800N-R
    Company Name
    MEDTRONIC PS MEDICAL, INC.
    Labeler DUNS
    089055867
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-05-01
    Public Version
    2
    Public Version Date
    2023-11-29
    Public Version Status
    Update
    Public Device Record Key
    e1e9db0b-5784-4421-8be3-118153782a28

    Device Description

    MOTOR EM800N-R MR8 ELEC NAVIGATED RFRB

    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    HAW Neurological stereotaxic Instrument

    GMDN Terms

    Code Name
    41264 Surgical power tool system control unit, line-powered

    Identifiers

    Type ID
    Primary 00763000063337

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K183644 000