BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    XPS® Magnum®

    DI: 00681490693943 · Model: 1897200T · MEDTRONIC XOMED, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    XPS® Magnum®
    Primary DI
    00681490693943
    Version / Model
    1897200T
    Company Name
    MEDTRONIC XOMED, INC.
    Labeler DUNS
    835465063
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-05
    Public Version
    5
    Public Version Date
    2019-02-19
    Public Version Status
    Update
    Public Device Record Key
    9b30bbd8-2c37-435e-b054-68419d21df7c
    Distribution End Date
    2018-10-24

    Device Description

    HANDPIECE 1897200T IGS MAGNUM II EN

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

    Product Codes

    Code Name
    ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

    GMDN Terms

    Code Name
    44491 Multi-purpose surgical power tool system, line-powered

    Identifiers

    Type ID
    Primary 00681490693943

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K041413 000