BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Plus Handpiece

    DI: 08034108512679 · Model: E098H1 · DEKA M.E.L.A. SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Plus Handpiece
    Primary DI
    08034108512679
    Version / Model
    E098H1
    Company Name
    DEKA M.E.L.A. SRL
    Labeler DUNS
    629381096
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-22
    Public Version
    1
    Public Version Date
    2025-10-30
    Public Version Status
    New
    Public Device Record Key
    877853ce-32cf-4b82-89c8-b2d60f9e9d21

    Device Description

    The Plus Handpiece is indicated for temporary increase in local blood circulation, and activation of connective tissue. The Plus Handpiece (Type B) is capable of emitting a pulsed "air massage" on the area to be treated. The Plus Handpiece is also equipped with an Off/On button.

    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
    Yes
    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
    ISA Massager, Therapeutic, Electric

    GMDN Terms

    Code Name
    36560 Hand-held electric massager

    Identifiers

    Type ID
    Primary 08034108512679