BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Ti-Max X

    DI: 04560264518513 · Model: X-SG25L · NAKANISHI INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Ti-Max X
    Primary DI
    04560264518513
    Version / Model
    X-SG25L
    Company Name
    NAKANISHI INC.
    Labeler DUNS
    690710546
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-16
    Public Version
    5
    Public Version Date
    2021-11-03
    Public Version Status
    Update
    Public Device Record Key
    152b11fe-cd3a-4d09-a302-8b3952ba1b81
    Distribution End Date
    2021-09-21

    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
    KMW HANDPIECE, ROTARY BONE CUTTING

    GMDN Terms

    Code Name
    38347 Dental power tool system handpiece, line-powered

    Identifiers

    Type ID
    Primary 04560264518513
    Direct Marking 04560264557130