BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NEWA PLUS Kit

    DI: 07290014660113 · Model: Plus, Gold · ENDYMED MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NEWA PLUS Kit
    Primary DI
    07290014660113
    Version / Model
    Plus, Gold
    Catalog Number
    ND_PRD00450-00
    Company Name
    ENDYMED MEDICAL LTD
    Labeler DUNS
    531958689
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-09
    Public Version
    2
    Public Version Date
    2023-11-21
    Public Version Status
    Update
    Public Device Record Key
    77d38495-d2e4-48d6-b46c-ae7c6a1c6320

    Device Description

    The EndyMed Newa Plus is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman with Fitzpatrick skin types I-IV.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    Yes
    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
    PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction

    GMDN Terms

    Code Name
    66988 Home-use radio-frequency skin contouring unit

    Identifiers

    Type ID
    Package 17290014660110
    Primary 07290014660113

    Customer Contacts

    Phone
    800-314-7508
    Email
    [email protected]