BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SureFlex NiTi Rotary File

    DI: D7166640011 · Model: 664001 · TULSA DENTAL PRODUCTS LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

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    Basic Information

    Brand Name
    SureFlex NiTi Rotary File
    Primary DI
    D7166640011
    Version / Model
    664001
    Catalog Number
    664001
    Company Name
    TULSA DENTAL PRODUCTS LLC
    Labeler DUNS
    942778564
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-10-27
    Public Version
    1
    Public Version Date
    2022-11-04
    Public Version Status
    New
    Public Device Record Key
    53875a3e-dbbc-45bc-9f62-a6ffda05bfc6

    Device Description

    SureFlex NiTi Rotory Files 015/21mm

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EFA Handpiece, belt and/or gear driven, dental

    GMDN Terms

    Code Name
    63550 Rotary/reciprocating endodontic file/rasp, single-use

    Identifiers

    Type ID
    Unit of Use D7166640010
    Primary D7166640011