BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EM3 Bipolar Adapter, Standard

    DI: 10815288014161 · Model: BP9004+ · ENCISION, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    EM3 Bipolar Adapter, Standard
    Primary DI
    10815288014161
    Version / Model
    BP9004+
    Catalog Number
    BP9004+
    Company Name
    ENCISION, INC.
    Labeler DUNS
    612250175
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-28
    Public Version
    1
    Public Version Date
    2022-03-08
    Public Version Status
    New
    Public Device Record Key
    a23d0121-a3b3-42a3-b2f1-ae0f99478da8

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    35041 Electrosurgical cable adaptor

    Identifiers

    Type ID
    Primary 10815288014161

    Premarket Submissions

    Submission Number Supplement Number
    K122383 000