BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Single-use Guidewire

    DI: 06971381251630 · Model: GW-3515 · SCIVITA MEDICAL TECHNOLOGY CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Single-use Guidewire
    Primary DI
    06971381251630
    Version / Model
    GW-3515
    Company Name
    SCIVITA MEDICAL TECHNOLOGY CO., LTD.
    Labeler DUNS
    544519831
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-05-24
    Public Version
    1
    Public Version Date
    2023-06-01
    Public Version Status
    New
    Public Device Record Key
    0b897bc6-6326-4fb8-bfb8-af1582839747

    Device Description

    The guide wire is an introducer, which uses the maneuverability and support characteristics of the guide wire to guide the catheter or other instrument into the cavity.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCY Endoscopic Guidewire, Gastroenterology-Urology

    GMDN Terms

    Code Name
    46691 Gastro-urological guidewire, single-use

    Identifiers

    Type ID
    Package 16971381251637
    Primary 06971381251630
    Package 26971381251634