BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Midas Rex MR8

    DI: 00643169912168 · Model: PM800N · MEDTRONIC POWERED SURGICAL SOLUTIONS
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Midas Rex MR8
    Primary DI
    00643169912168
    Version / Model
    PM800N
    Company Name
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Labeler DUNS
    098308849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-08
    Public Version
    2
    Public Version Date
    2023-11-30
    Public Version Status
    Update
    Public Device Record Key
    9e41d250-4bdf-4356-aa45-f7e0ad72bdbe

    Device Description

    MOTOR PM800N MR8 PNEUMATIC NAVIGATED S8

    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
    Dry Heat Sterilization

    Product Codes

    Code Name
    OLO Orthopedic stereotaxic instrument
    HAW Neurological stereotaxic Instrument

    GMDN Terms

    Code Name
    41267 Surgical power tool system control unit, pneumatic

    Identifiers

    Type ID
    Primary 00643169912168

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K183644 000