BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Midas Rex™

    DI: 00643169789708 · Model: EA100 · MEDTRONIC POWERED SURGICAL SOLUTIONS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Midas Rex™
    Primary DI
    00643169789708
    Version / Model
    EA100
    Company Name
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Labeler DUNS
    098308849
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-02
    Public Version
    10
    Public Version Date
    2022-09-16
    Public Version Status
    Update
    Public Device Record Key
    2829d4c7-de2b-4fc3-929f-307cbffa8bf7

    Device Description

    INSTRUMENT TRAY EA100 LEGEND EHS STYLUS

    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
    Yes
    Sterilization Methods
    ["Moist Heat or Steam Sterilization", "Ethylene Oxide"]

    Product Codes

    Code Name
    HBE DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

    GMDN Terms

    Code Name
    12143 Instrument tray, reusable

    Identifiers

    Type ID
    Primary 00643169789708

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K170312 000