BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Omni

    DI: 00812231034453 · Model: 83-10-1500 · SANTA BARBARA IMAGING SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Omni
    Primary DI
    00812231034453
    Version / Model
    83-10-1500
    Company Name
    SANTA BARBARA IMAGING SYSTEMS, INC.
    Labeler DUNS
    065016344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-06-24
    Public Version
    1
    Public Version Date
    2024-07-02
    Public Version Status
    New
    Public Device Record Key
    de6706a9-7a76-48f4-aa47-7ee57e2798b1

    Device Description

    OMNI 4K HDR SYSTEM, TABLET

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GCJ Laparoscope, General & Plastic Surgery

    GMDN Terms

    Code Name
    61583 Endoscopic device remote control

    Identifiers

    Type ID
    Primary 00812231034453

    Customer Contacts

    Phone
    805-770-2110
    Email
    [email protected]