BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ONE SHAPE APICAL

    DI: J015209492121 · Model: n037 6% L25 · MICRO MEGA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    5

    Basic Information

    Brand Name
    ONE SHAPE APICAL
    Primary DI
    J015209492121
    Version / Model
    n037 6% L25
    Catalog Number
    20949212
    Company Name
    MICRO MEGA
    Labeler DUNS
    276075371
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    5
    Record Status
    Published
    Publish Date
    2020-08-28
    Public Version
    1
    Public Version Date
    2020-09-07
    Public Version Status
    New
    Public Device Record Key
    2165b52a-d3f0-4c70-981d-90cad0434ace

    Device Description

    Endodontic instrument for professionnal dental use only

    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
    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
    63550 Rotary/reciprocating endodontic file/rasp, single-use

    Identifiers

    Type ID
    Package J015209492129
    Primary J015209492121
    Unit of Use J015209492120

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep dry
    Type
    Special Storage Condition, Specify
    Special Conditions
    Keep away from sunlight