BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ESU Shroud

    DI: 00817688021940 · Model: ICM-000-0175 · I.C. MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    25

    Basic Information

    Brand Name
    ESU Shroud
    Primary DI
    00817688021940
    Version / Model
    ICM-000-0175
    Company Name
    I.C. MEDICAL, INC.
    Labeler DUNS
    616182895
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    6
    Public Version Date
    2023-08-09
    Public Version Status
    Update
    Public Device Record Key
    5482f08f-8c69-45c3-88ee-ba0f8a7a8f25
    Distribution End Date
    2022-09-21

    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
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    46483 Surgical plume evacuation system tube

    Identifiers

    Type ID
    Primary 00817688021940
    Unit of Use 00817688021148