BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ESU Shroud

    DI: 00817688022640 · Model: ICM-000-0598 · I.C. MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ESU Shroud
    Primary DI
    00817688022640
    Version / Model
    ICM-000-0598
    Catalog Number
    ICM-000-0598
    Company Name
    I.C. MEDICAL, INC.
    Labeler DUNS
    616182895
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-08
    Public Version
    1
    Public Version Date
    2023-03-16
    Public Version Status
    New
    Public Device Record Key
    5d251daf-5732-46c2-8b71-5be7d3f53914

    Device Description

    ESU Shroud, Short Tip, 1’ Tube, Sterile

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    46483 Surgical plume evacuation system tube

    Identifiers

    Type ID
    Package 00817688022657
    Primary 00817688022640

    Customer Contacts

    Phone
    623-780-0700
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    0 – 140 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    30 – 85 Percent (%) Relative Humidity