BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    STAR Tumor Ablation Kit (5|10, Short) with PowerCURVE

    DI: 00850696006264 · Model: RF-0510S-01 · Dfine, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    STAR Tumor Ablation Kit (5|10, Short) with PowerCURVE
    Primary DI
    00850696006264
    Version / Model
    RF-0510S-01
    Catalog Number
    RF-0510S-01
    Company Name
    Dfine, Inc.
    Labeler DUNS
    169957607
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-23
    Public Version
    5
    Public Version Date
    2020-04-13
    Public Version Status
    Update
    Public Device Record Key
    263423d7-9ee3-44c4-8cc3-029ded39ab8a
    Distribution End Date
    2020-04-10

    Device Description

    ala carte packaging

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    57972 Radio-frequency ablation system

    Identifiers

    Type ID
    Primary 00850696006264

    Premarket Submissions

    Submission Number Supplement Number
    K091310 000