BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    VS3 Iridium Endoscope-IR 5.5mm, Long, 0°, Standard FOV - Refurbished

    DI: 10813040013247 · Model: VS3-IR · VISIONSENSE LTD.
    View on AccessGUDID
    Product Codes
    4
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VS3 Iridium Endoscope-IR 5.5mm, Long, 0°, Standard FOV - Refurbished
    Primary DI
    10813040013247
    Version / Model
    VS3-IR
    Catalog Number
    153-0051RFB
    Company Name
    VISIONSENSE LTD.
    Labeler DUNS
    532199478
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-07
    Public Version
    2
    Public Version Date
    2022-02-16
    Public Version Status
    Update
    Public Device Record Key
    f2084b14-8c2b-4aac-816d-3161e1a1229d
    Distribution End Date
    2022-02-15

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GWG Endoscope, Neurological
    OWN Confocal Optical Imaging
    GCJ Laparoscope, General & Plastic Surgery
    HRX Arthroscope

    GMDN Terms

    Code Name
    35958 Endoscope video camera

    Identifiers

    Type ID
    Primary 10813040013247

    Premarket Submissions

    Submission Number Supplement Number
    K152204 000