BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Non-Telescopic PenEvac

    DI: 00817688022008 · Model: ICM-000-0540 · I.C. MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    Non-Telescopic PenEvac
    Primary DI
    00817688022008
    Version / Model
    ICM-000-0540
    Company Name
    I.C. MEDICAL, INC.
    Labeler DUNS
    616182895
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2019-04-08
    Public Version Status
    Update
    Public Device Record Key
    e417e033-d584-4c82-9d32-631d6eb26ff7

    Device Characteristics

    Single Use
    Yes
    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
    MR Unsafe
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    61869 Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

    Identifiers

    Type ID
    Primary 00817688022008
    Unit of Use 00817688020813