BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EU－Scope

    DI: 06970034210130 · Model: US31B-12 · Shanghai AnQing Medical Instrument Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EU－Scope
    Primary DI
    06970034210130
    Version / Model
    US31B-12
    Company Name
    Shanghai AnQing Medical Instrument Co., Ltd
    Labeler DUNS
    544581269
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-22
    Public Version
    5
    Public Version Date
    2022-10-17
    Public Version Status
    Update
    Public Device Record Key
    2eff9667-f5b2-4e68-9ec8-c402f580aaae

    Device Description

    Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed DOSTM video processor approved by SHANGHAI ANQING.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    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
    38689 Flexible video ureteroscope, reusable

    Identifiers

    Type ID
    Primary 06970034210130