BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Zutron Medical

    DI: 00817658020188 · Model: ZUTR162000 · ZUTRON MEDICAL, L.L.C.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Zutron Medical
    Primary DI
    00817658020188
    Version / Model
    ZUTR162000
    Catalog Number
    ZUTR162000
    Company Name
    ZUTRON MEDICAL, L.L.C.
    Labeler DUNS
    962532441
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-01
    Public Version
    3
    Public Version Date
    2024-04-30
    Public Version Status
    Update
    Public Device Record Key
    8a5efee5-d1c7-4a08-8ee3-df7a7adca808
    Distribution End Date
    2024-04-29

    Device Description

    The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope Stiffening Device.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes.

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization, High-level Disinfectant, Ethylene Oxide

    Product Codes

    Code Name
    FDF Colonoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    17826 Colonoscope stiffener

    Identifiers

    Type ID
    Primary 00817658020188