BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Andorate®

    DI: 06970661241033 · Model: GAR004C · Smartdata Suzhou Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Andorate®
    Primary DI
    06970661241033
    Version / Model
    GAR004C
    Company Name
    Smartdata Suzhou Co., Ltd.
    Labeler DUNS
    529507479
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-10-02
    Public Version
    2
    Public Version Date
    2019-10-02
    Public Version Status
    Update
    Public Device Record Key
    918fae32-7cd7-4ea2-b4fa-a04a8cad7b0e

    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
    OCX Endoscopic Irrigation/Suction System

    GMDN Terms

    Code Name
    60760 Endoscope channel support kit

    Identifiers

    Type ID
    Package 16970661241030
    Primary 06970661241033
    Package 26970661241037