BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accu Trac

    DI: D661ATR1441 · Model: ATR144 · COLTENE/WHALEDENT INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    144

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    Basic Information

    Brand Name
    Accu Trac
    Primary DI
    D661ATR1441
    Version / Model
    ATR144
    Company Name
    COLTENE/WHALEDENT INC
    Labeler DUNS
    622185718
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    144
    Record Status
    Published
    Publish Date
    2019-02-26
    Public Version
    1
    Public Version Date
    2019-03-11
    Public Version Status
    New
    Public Device Record Key
    28d8beba-040d-4c42-8008-96f745879af7

    Device Description

    Refill Kit - Economy

    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
    Yes
    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
    No

    Product Codes

    Code Name
    NDP Accessories, Implant, Dental, Endosseous

    GMDN Terms

    Code Name
    61648 Dental prosthesis bite verification device

    Identifiers

    Type ID
    Primary D661ATR1441
    Unit of Use D661ATR1440