BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disc-FX® Mini System

    DI: 00846338001384 · Model: DFXM · ELLIQUENCE, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Disc-FX® Mini System
    Primary DI
    00846338001384
    Version / Model
    DFXM
    Company Name
    ELLIQUENCE, LLC
    Labeler DUNS
    019872358
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-02-03
    Public Version
    3
    Public Version Date
    2019-04-23
    Public Version Status
    Update
    Public Device Record Key
    0cdf3ec3-674b-4d6d-a65d-5523fbf48e4b

    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
    HRX Arthroscope

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00846338001384