BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SynchroWave ST Antenna

    DI: 00810563021035 · Model: 22-17025-315 · VARIAN MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SynchroWave ST Antenna
    Primary DI
    00810563021035
    Version / Model
    22-17025-315
    Catalog Number
    SWST-1415
    Company Name
    VARIAN MEDICAL SYSTEMS, INC.
    Labeler DUNS
    009120817
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-18
    Public Version
    2
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    f703fcb8-7bc3-410d-af9b-888ef7dd18dc

    Device Description

    Short Tip Microwave Antenna Kit (15 cm, 1 per Tray)

    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
    MR Unsafe
    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
    NEY SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

    GMDN Terms

    Code Name
    61286 Microwave ablation system probe, non-powered

    Identifiers

    Type ID
    Primary 00810563021035

    Premarket Submissions

    Submission Number Supplement Number
    K141785 000