BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    G-FILES

    DI: J015201480011 · Model: L21 2xG1 2xG2 · MICRO MEGA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    4

    Basic Information

    Brand Name
    G-FILES
    Primary DI
    J015201480011
    Version / Model
    L21 2xG1 2xG2
    Catalog Number
    20148001
    Company Name
    MICRO MEGA
    Labeler DUNS
    276075371
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2020-09-01
    Public Version
    1
    Public Version Date
    2020-09-09
    Public Version Status
    New
    Public Device Record Key
    ef3db238-5068-498f-8a60-b8cd5e1fb778

    Device Description

    Endodontic instrument for professionnal dental use only

    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
    Yes
    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
    40529 Rotary/reciprocating endodontic file/rasp, reusable

    Identifiers

    Type ID
    Primary J015201480011
    Package J015201480019
    Unit of Use J015201480010