BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    K-Files 31mm 070, pu: 6 pcs

    DI: 07630049996571 · Model: 131031.070 · Diaswiss SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    K-Files 31mm 070, pu: 6 pcs
    Primary DI
    07630049996571
    Version / Model
    131031.070
    Company Name
    Diaswiss SA
    Labeler DUNS
    480296552
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2023-10-02
    Public Version
    1
    Public Version Date
    2023-10-10
    Public Version Status
    New
    Public Device Record Key
    e48cd1c3-8e5b-43fd-a8db-6c2c5d92a985

    Device Description

    Manual instrument for endodontic intraoral use

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    EKS FILE, PULP CANAL, ENDODONTIC

    GMDN Terms

    Code Name
    31878 Manual endodontic file/rasp, reusable

    Identifiers

    Type ID
    Unit of Use 07630049991026
    Primary 07630049996571