BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    FullFire® Diffusing Tip Laser Probe

    DI: 00816589020106 · Model: 20414-00 · MONTERIS MEDICAL INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FullFire® Diffusing Tip Laser Probe
    Primary DI
    00816589020106
    Version / Model
    20414-00
    Catalog Number
    DTP-001-01
    Company Name
    MONTERIS MEDICAL INC
    Labeler DUNS
    021415875
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-02
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2396eefc-6080-4dab-8192-cc6dc7f7ac8a
    Distribution End Date
    2017-03-10

    Device Description

    3.3mm Diffusing Tip Laser Probe

    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
    MR Conditional
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    62268 MRI-guided laser interstitial thermal therapy system beam guide

    Identifiers

    Type ID
    Primary 00816589020106

    Customer Contacts

    Phone
    +1(866)799-7655
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Size 00
    Outer Diameter 3.3 Millimeter