BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NEWA Kit

    DI: 07290014660083 · Model: 1.5, Black · ENDYMED MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NEWA Kit
    Primary DI
    07290014660083
    Version / Model
    1.5, Black
    Catalog Number
    ND_PRD00446-00
    Company Name
    ENDYMED MEDICAL LTD
    Labeler DUNS
    531958689
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-09-23
    Public Version
    2
    Public Version Date
    2023-11-21
    Public Version Status
    Update
    Public Device Record Key
    3bdf3fd8-9864-44fe-9c1c-0d09b2fae230

    Device Description

    The EndyMed Newa 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
    Primary 07290014660083
    Package 17290014660080

    Customer Contacts

    Phone
    800-314-7508
    Email
    [email protected]