BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Flex-X

    DI: 04048551416969 · Model: 11278VSUE · Karl Storz GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Flex-X
    Primary DI
    04048551416969
    Version / Model
    11278VSUE
    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
    2020-01-11
    Public Version
    2
    Public Version Date
    2021-05-10
    Public Version Status
    Update
    Public Device Record Key
    69ab09b7-bd18-4ac3-af21-b666ea861866

    Device Description

    Video Uretero-Renoscope FLEX-X C

    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
    Yes
    Sterilization Methods
    ["Peracetic Acid", "Ethylene Oxide", "High-level Disinfectant", "Hydrogen Peroxide"]

    Product Codes

    Code Name
    FGB Ureteroscope and accessories, flexible/rigid

    GMDN Terms

    Code Name
    38703 Flexible video ureterorenoscope, reusable

    Identifiers

    Type ID
    Primary 04048551416969

    Premarket Submissions

    Submission Number Supplement Number
    K141250 000