BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Precise LTM Diode Laser

    DI: 00872320001360 · Model: 002-00176 · CAO GROUP, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Precise LTM Diode Laser
    Primary DI
    00872320001360
    Version / Model
    002-00176
    Catalog Number
    002-00176
    Company Name
    CAO GROUP, INC.
    Labeler DUNS
    102422578
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-10
    Public Version
    4
    Public Version Date
    2018-11-08
    Public Version Status
    Update
    Public Device Record Key
    f468b071-4594-4475-9869-7fef1ce9c008

    Device Description

    Diode laser for dental soft tissue treatments and procedures.

    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
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Primary 00872320001360

    Customer Contacts

    Phone
    877-236-4408
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K062619 000