BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Refurbished ,SubQ applicator, Packaged, Profound

    DI: 07290109952635 · Model: FG71501R · SYNERON MEDICAL LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Refurbished ,SubQ applicator, Packaged, Profound
    Primary DI
    07290109952635
    Version / Model
    FG71501R
    Catalog Number
    FG71501R
    Company Name
    SYNERON MEDICAL LTD
    Labeler DUNS
    532685716
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-21
    Public Version
    5
    Public Version Date
    2023-10-17
    Public Version Status
    Update
    Public Device Record Key
    1b29b0aa-969f-407c-8722-0a26334137cd
    Distribution End Date
    2023-10-16

    Device Description

    Refurbished ,SubQ applicator, Packaged, Profound

    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories
    PBX Massager, Vacuum, Radio Frequency Induced Heat

    GMDN Terms

    Code Name
    45220 Multi-modality skin surface treatment system

    Identifiers

    Type ID
    Primary 07290109952635

    Premarket Submissions

    Submission Number Supplement Number
    K161043 000