BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pioneer Elite Ergonomic Handpiece Sleeve

    DI: 00872320000868 · Model: 04073 · CAO GROUP, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pioneer Elite Ergonomic Handpiece Sleeve
    Primary DI
    00872320000868
    Version / Model
    04073
    Company Name
    CAO GROUP, INC.
    Labeler DUNS
    102422578
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-08-17
    Public Version
    6
    Public Version Date
    2019-12-04
    Public Version Status
    Update
    Public Device Record Key
    63053f7b-ff23-4392-99dd-3f8f8089ab33

    Device Description

    Removable surgical handpiece sleeve for the Pioneer Elite Diode Laser.

    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
    No
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    60340 Dental diode laser system

    Identifiers

    Type ID
    Package 00872320001605
    Primary 00872320000868
    Package 00872320004903

    Customer Contacts

    Phone
    801-256-9282
    Email
    [email protected]
    Phone
    866-999-2635
    Email
    [email protected]