BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INT,Falcon Guide Wire

    DI: 06950900959226 · Model: HG284AF · Shanghai Kindly Medical Instruments Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INT,Falcon Guide Wire
    Primary DI
    06950900959226
    Version / Model
    HG284AF
    Company Name
    Shanghai Kindly Medical Instruments Co., Ltd.
    Labeler DUNS
    420827639
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-21
    Public Version
    1
    Public Version Date
    2023-08-29
    Public Version Status
    New
    Public Device Record Key
    e0fcd50e-5bc6-4997-b580-24fdf38793fd

    Device Description

    0.028“*180cm, hydrophilic coating, angled tip

    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
    No
    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
    DQX Wire, Guide, Catheter

    GMDN Terms

    Code Name
    35094 Cardiac/peripheral vascular guidewire, single-use

    Identifiers

    Type ID
    Package 26950900959220
    Primary 06950900959226
    Package 46950900959224

    Premarket Submissions

    Submission Number Supplement Number
    K180177 000