BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MANI MEDIUM FLARE FILES

    DI: 04546951504366 · Model: 21mm SIZE 22 · MANI, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    MANI MEDIUM FLARE FILES
    Primary DI
    04546951504366
    Version / Model
    21mm SIZE 22
    Company Name
    MANI, INC.
    Labeler DUNS
    690622428
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2022-10-08
    Public Version
    1
    Public Version Date
    2022-10-17
    Public Version Status
    New
    Public Device Record Key
    28549a4e-c09f-4796-9082-5696be9786a1

    Device Description

    MANI FLARE FILES

    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
    Yes
    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 74546951504365
    Primary 04546951504366