BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Visualase

    DI: 00643169655935 · Model: 9735542 · MEDTRONIC NAVIGATION, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Visualase
    Primary DI
    00643169655935
    Version / Model
    9735542
    Company Name
    MEDTRONIC NAVIGATION, INC.
    Labeler DUNS
    835233107
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-01
    Public Version
    5
    Public Version Date
    2023-12-25
    Public Version Status
    Update
    Public Device Record Key
    1722e86c-47a2-4a12-b1c9-aeece2291e01
    Distribution End Date
    2023-05-24

    Device Description

    SYSTEM 9735542 15W VISUALASE

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered laser surgical instrument
    ONO Neurosurgical laser with MR thermography

    GMDN Terms

    Code Name
    60341 General/multiple surgical diode laser system

    Identifiers

    Type ID
    Primary 00643169655935

    Customer Contacts

    Phone
    +1(800)633-8766
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K081656 000