BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Edge X7 Utopia

    DI: 07640142445289 · Model: X7U450629SE · FKG Dentaire Sàrl
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    6

    Basic Information

    Brand Name
    Edge X7 Utopia
    Primary DI
    07640142445289
    Version / Model
    X7U450629SE
    Catalog Number
    X7U450629SE
    Company Name
    FKG Dentaire Sàrl
    Labeler DUNS
    482884061
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    6
    Record Status
    Published
    Publish Date
    2023-04-19
    Public Version
    1
    Public Version Date
    2023-04-27
    Public Version Status
    New
    Public Device Record Key
    b8ac79ec-995a-42c6-93fa-44c9cc5a1178

    Device Description

    Edge X7 Utopia no 45, 06, 29mm

    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
    No
    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
    Unit of Use 07640142444466
    Primary 07640142445289