BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Refurbished, CO2RE System for US, Packaged

    DI: 07290109952666 · Model: FG70412USR · SYNERON MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Refurbished, CO2RE System for US, Packaged
    Primary DI
    07290109952666
    Version / Model
    FG70412USR
    Catalog Number
    FG70412USR
    Company Name
    SYNERON MEDICAL LTD
    Labeler DUNS
    532685716
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-01
    Public Version
    7
    Public Version Date
    2023-10-17
    Public Version Status
    Update
    Public Device Record Key
    7cfaab67-f8a7-43f0-882d-d00b15dce58e
    Distribution End Date
    2023-10-16

    Device Description

    Refurbished, CO2RE System for US, Packaged

    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
    No
    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
    61473 Dermatological carbon dioxide laser system

    Identifiers

    Type ID
    Primary 07290109952666

    Premarket Submissions

    Submission Number Supplement Number
    K181523 000