BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dimed

    DI: 00860014872211 · Model: DM241117R1 · CURE POINT THERAPEUTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dimed
    Primary DI
    00860014872211
    Version / Model
    DM241117R1
    Company Name
    CURE POINT THERAPEUTICS, INC.
    Labeler DUNS
    114176021
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-29
    Public Version
    1
    Public Version Date
    2025-11-06
    Public Version Status
    New
    Public Device Record Key
    b6ea1467-11c9-418c-a955-3fc08ad2629d

    Device Description

    Fiber Optic Cable: Attaches to Class 4 - Sirona 100 Therapy Laser system Used in RX medical treatments. Considered part of the Sirona 100 Therapy Laser System, but pieces are packaged separately and intended to be used as part of the device.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60341 General/multiple surgical diode laser system

    Identifiers

    Type ID
    Primary 00860014872211