BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EndoPilot contra-angle

    DI: 04260482990091 · Model: 1:1 · Schlumbohm GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EndoPilot contra-angle
    Primary DI
    04260482990091
    Version / Model
    1:1
    Catalog Number
    109 0126
    Company Name
    Schlumbohm GmbH & Co. KG
    Labeler DUNS
    343831731
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-25
    Public Version
    1
    Public Version Date
    2021-06-02
    Public Version Status
    New
    Public Device Record Key
    d44828a1-9b99-4202-bad3-57c744757dac

    Device Description

    EndoPilot contra-angle for apexlocation full isolated transmission 1:1 with ISO-E standard

    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
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    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
    EKX Handpiece, Direct Drive, Ac-Powered

    GMDN Terms

    Code Name
    38347 Dental power tool system handpiece, line-powered

    Identifiers

    Type ID
    Primary 04260482990091

    Premarket Submissions

    Submission Number Supplement Number
    K202906 000