BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KOMET Root Canal Files

    DI: E226007162A31 · Model: 17321.654.020.A3 · Gebr. Brasseler GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    KOMET Root Canal Files
    Primary DI
    E226007162A31
    Version / Model
    17321.654.020.A3
    Catalog Number
    17321.654.020
    Company Name
    Gebr. Brasseler GmbH & Co. KG
    Labeler DUNS
    317409001
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2023-08-25
    Public Version
    1
    Public Version Date
    2023-09-04
    Public Version Status
    New
    Public Device Record Key
    c1f8b899-62f4-48a2-aa04-5240294c5c5b

    Device Characteristics

    Single Use
    Yes
    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
    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 E226007162A38
    Primary E226007162A31