BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Midas Rex MR8

    DI: 00643169912137 · Model: PM800 · 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
    00643169912137
    Version / Model
    PM800
    Company Name
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Labeler DUNS
    098308849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-06-08
    Public Version
    2
    Public Version Date
    2023-11-30
    Public Version Status
    Update
    Public Device Record Key
    f6776cfd-2dcf-447f-a15c-0b3f9e079ae5

    Device Description

    MOTOR PM800 MR8 PNEUMATIC

    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
    ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
    HBB MOTOR, DRILL, PNEUMATIC

    GMDN Terms

    Code Name
    41267 Surgical power tool system control unit, pneumatic

    Identifiers

    Type ID
    Primary 00643169912137

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K163565 000