BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Radiance

    DI: 00818089022772 · Model: 90X0721 · Nds Surgical Imaging LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Radiance
    Primary DI
    00818089022772
    Version / Model
    90X0721
    Company Name
    Nds Surgical Imaging LLC
    Labeler DUNS
    081712583
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-15
    Public Version
    4
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    b788ff14-b0f8-46e5-953b-a702d6c9223b
    Distribution End Date
    2021-12-30

    Device Description

    Smith & Nephew, RADIANCE ULTRA 32" 4K, 4X SDI, SC-WK32-G1B24

    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
    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
    KQM Camera, Surgical And Accessories

    GMDN Terms

    Code Name
    36612 Image display unit, colour

    Identifiers

    Type ID
    Primary 00818089022772