BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EMSCULPT NEO

    DI: B108899PO11C1ENUS0150 · Model: EMSCULPT NEO · BTL INDUSTRIES LIMITED
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    EMSCULPT NEO
    Primary DI
    B108899PO11C1ENUS0150
    Version / Model
    EMSCULPT NEO
    Company Name
    BTL INDUSTRIES LIMITED
    Labeler DUNS
    733532951
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-23
    Public Version
    2
    Public Version Date
    2026-01-16
    Public Version Status
    Update
    Public Device Record Key
    dbf99b8c-77ec-45fb-8881-be8cf77eea8d

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NGX Stimulator, Muscle, Powered, For Muscle Conditioning
    IPF Stimulator, Muscle, Powered
    QPL Electromagnetic Stimulator, Pain Relief

    GMDN Terms

    Code Name
    40785 Multi-modality hyperthermia system

    Identifiers

    Type ID
    Primary B108899PO11C1ENUS0150