BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    n.a.

    DI: 04048551418123 · Model: TC304US · Karl Storz GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    n.a.
    Primary DI
    04048551418123
    Version / Model
    TC304US
    Catalog Number
    TC304US
    Company Name
    Karl Storz GmbH & Co. KG
    Labeler DUNS
    315731430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-08-11
    Public Version
    1
    Public Version Date
    2025-08-19
    Public Version Status
    New
    Public Device Record Key
    02c61f0f-7525-487d-b8da-c8d945f42c0e

    Device Description

    IMAGE1 S 4U-LINK

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OWN Confocal optical imaging
    FET Endoscopic video imaging system/component, gastroenterology-urology
    GWG Endoscope, neurological

    GMDN Terms

    Code Name
    36739 Camera control unit

    Identifiers

    Type ID
    Primary 04048551418123