BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EndoPilot apex cable set

    DI: 04260482990282 · Model: EDP2 · Schlumbohm GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EndoPilot apex cable set
    Primary DI
    04260482990282
    Version / Model
    EDP2
    Catalog Number
    109 2311
    Company Name
    Schlumbohm GmbH & Co. KG
    Labeler DUNS
    343831731
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-31
    Public Version
    1
    Public Version Date
    2021-06-08
    Public Version Status
    New
    Public Device Record Key
    2384df8d-de39-4857-bba0-0a1df5d95d78

    Device Description

    Apex-cable-Set for Endopilot, consist of: 1x measuring cable with plug; 1x lip clip; 1x cap for lip contact; 1x cable for file clamp; 1x file clamp, dismountable; 1x Bushing for lip-clip cable-socket

    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
    No
    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
    ["High-level Disinfectant", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    LQY Locator, Root Apex

    GMDN Terms

    Code Name
    16355 Endodontic apex locator

    Identifiers

    Type ID
    Primary 04260482990282

    Premarket Submissions

    Submission Number Supplement Number
    K202906 000