BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Trigger-Flex® Dart Bipolar System

    DI: 00846338001407 · Model: DTFD-24 · ELLIQUENCE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Trigger-Flex® Dart Bipolar System
    Primary DI
    00846338001407
    Version / Model
    DTFD-24
    Company Name
    ELLIQUENCE, LLC
    Labeler DUNS
    019872358
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-26
    Public Version
    2
    Public Version Date
    2019-04-23
    Public Version Status
    Update
    Public Device Record Key
    03060134-6dec-4eec-88c0-446db30f21de

    Device Characteristics

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    57944 Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

    Identifiers

    Type ID
    Primary 00846338001407