BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sunoptic Surgical, CUDA, Sunoptic Technologies, OEM Customer

    DI: M678DPLS400W0 · Model: DPLS-02, DPLS-04 · 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 Surgical, CUDA, Sunoptic Technologies, OEM Customer
    Primary DI
    M678DPLS400W0
    Version / Model
    DPLS-02, DPLS-04
    Company Name
    SUNOPTIC TECHNOLOGIES LLC
    Labeler DUNS
    094586898
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-01
    Public Version
    1
    Public Version Date
    2023-03-09
    Public Version Status
    New
    Public Device Record Key
    b9a9c21d-5e0a-41ce-95cd-951de59014ff

    Device Description

    Xenon Lightsource, 400 Watt, Digital

    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 M678DPLS400W0