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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sunoptic Technologies

    DI: M678XLS0 · Model: XLS series Xenon Lightsource · SUNOPTIC TECHNOLOGIES LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sunoptic Technologies
    Primary DI
    M678XLS0
    Version / Model
    XLS series Xenon Lightsource
    Company Name
    SUNOPTIC TECHNOLOGIES LLC
    Labeler DUNS
    094586898
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-29
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b553e8c3-b3dc-4354-9d36-0e1ee02a5fc5

    Device Description

    XLS series Xenon lightsource

    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
    Yes
    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
    No

    Product Codes

    Code Name
    FSS Light, Surgical, Floor Standing

    GMDN Terms

    Code Name
    32037 General-purpose light source

    Identifiers

    Type ID
    Primary M678XLS0

    Customer Contacts

    Phone
    9047377611
    Email
    [email protected]