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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Endovenous Radiofrequency Ablation (RFA) Catheter

    DI: 00860036000562 · Model: VEN-3-60 · Vein360 LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Endovenous Radiofrequency Ablation (RFA) Catheter
    Primary DI
    00860036000562
    Version / Model
    VEN-3-60
    Catalog Number
    VEN-3-60
    Company Name
    Vein360 LLC
    Labeler DUNS
    080926907
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-26
    Public Version
    1
    Public Version Date
    2021-11-03
    Public Version Status
    New
    Public Device Record Key
    5dff9603-80d6-489b-bf43-6b5db1c92b61

    Device Description

    Endovenous Radiofrequency Ablation (RFA) Catheter 3-60

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    57972 Radio-frequency ablation system

    Identifiers

    Type ID
    Package 10860036000569
    Primary 00860036000562
    Previous 08600360005022