BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TT Transformer

    DI: 08055728580008 · Model: 01 · TT TOOTH TRANSFORMER SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TT Transformer
    Primary DI
    08055728580008
    Version / Model
    01
    Catalog Number
    TT8001
    Company Name
    TT TOOTH TRANSFORMER SRL
    Labeler DUNS
    437311340
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-06-29
    Public Version
    1
    Public Version Date
    2022-07-07
    Public Version Status
    New
    Public Device Record Key
    38401ac9-16ed-4176-a537-0692c534698a

    Device Description

    AC-powered Medical Device which allows automatic preparation of dentinal autologous material, starting from a tooth of a patient, in order to make it usable for bone regeneration, by the action of a motor that provides power to operate blades that reduce the tooth into granules.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEY Motor, Surgical Instrument, Ac-Powered

    GMDN Terms

    Code Name
    63369 Tooth mill

    Identifiers

    Type ID
    Primary 08055728580008