BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    KOMET Spreader

    DI: E226006827A31 · Model: 9107.654.035.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 Spreader
    Primary DI
    E226006827A31
    Version / Model
    9107.654.035.A3
    Catalog Number
    9107.654.035
    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
    bee4a91b-2a4f-473a-ab40-947c528379ad

    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
    EKK SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

    GMDN Terms

    Code Name
    63720 Manual endodontic file/rasp, single-use

    Identifiers

    Type ID
    Unit of Use E226006827A38
    Primary E226006827A31