BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OMNIsEMG

    DI: B179OMN · Model: 1.0 · BTS SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    OMNIsEMG
    Primary DI
    B179OMN
    Version / Model
    1.0
    Catalog Number
    BTSEMB1BM
    Company Name
    BTS SPA
    Labeler DUNS
    428484518
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-12
    Public Version
    3
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    583fd83c-f843-445b-80ee-052324177db7

    Device Description

    BTS OMNIsEMG is an instrument for the electromyographic surface analysis.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    Yes
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HCC Device, Biofeedback

    GMDN Terms

    Code Name
    11474 Electromyograph

    Identifiers

    Type ID
    Primary B179OMN