BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WiScope®

    DI: 06972084140108 · Model: OTU-C380SR · Ningbo Wise Optomech Technology Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WiScope®
    Primary DI
    06972084140108
    Version / Model
    OTU-C380SR
    Company Name
    Ningbo Wise Optomech Technology Corporation
    Labeler DUNS
    540094524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-01-22
    Public Version
    3
    Public Version Date
    2023-06-08
    Public Version Status
    Update
    Public Device Record Key
    8d047c09-a467-456a-bbc1-99e6542f9120

    Device Description

    Single-Use Digital Flexible UroScope

    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
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FGB Ureteroscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    64074 Flexible video ureteroscope, single-use

    Identifiers

    Type ID
    Package 16972084140105
    Primary 06972084140108
    Package 26972084140102
    Package 36972084140109