BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KOMET Root Canal Files

    DI: E226048435G11 · Model: OP08L19.204.025.G1 · 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
    E226048435G11
    Version / Model
    OP08L19.204.025.G1
    Catalog Number
    OP08L19.204.025
    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
    2023-02-01
    Public Version
    1
    Public Version Date
    2023-02-09
    Public Version Status
    New
    Public Device Record Key
    576071bb-52e0-4848-90b5-583c962fa448

    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
    Yes
    PM Exempt
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EKS FILE, PULP CANAL, ENDODONTIC

    GMDN Terms

    Code Name
    35784 Endodontic broach, serrated, reusable

    Identifiers

    Type ID
    Unit of Use E226048435G18
    Primary E226048435G11