BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Empelvic

    DI: 00384703160019 · Model: SM 3160 · OWEN MUMFORD USA INCORPORATED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Empelvic
    Primary DI
    00384703160019
    Version / Model
    SM 3160
    Company Name
    OWEN MUMFORD USA INCORPORATED
    Labeler DUNS
    803401454
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-22
    Public Version
    2
    Public Version Date
    2025-09-08
    Public Version Status
    Update
    Public Device Record Key
    d68cf06d-6ccc-4362-a579-6e743980b6ef

    Device Description

    Pelvic Floor Trainer - Femail

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ION Exerciser, Non-Measuring

    GMDN Terms

    Code Name
    41571 Custom-made cushion

    Identifiers

    Type ID
    Primary 00384703160019