BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    X-Smart® Go Protective silicone sleeve

    DI: D100B00XSGOAC0007 · Model: 1 · FORUM ENGINEERING TECHNOLOGIES (96) LTD.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    2
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    X-Smart® Go Protective silicone sleeve
    Primary DI
    D100B00XSGOAC0007
    Version / Model
    1
    Catalog Number
    B00XSGOAC0007
    Company Name
    FORUM ENGINEERING TECHNOLOGIES (96) LTD.
    Labeler DUNS
    532219235
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-01-23
    Public Version
    1
    Public Version Date
    2026-02-02
    Public Version Status
    New
    Public Device Record Key
    1169b9be-80f6-40da-b5e2-149edca96321

    Device Description

    A silicon cover which must be changed after each patient and provides a layer of protection against disinfection agent

    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
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    LQY Locator, Root Apex
    EKX Handpiece, Direct Drive, Ac-Powered

    GMDN Terms

    Code Name
    16355 Endodontic apex locator
    66245 Dental surgical power tool motorized handpiece/set, electric

    Identifiers

    Type ID
    Primary D100B00XSGOAC0007