BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    UBM Plus: Software Package

    DI: 00897826002161 · Model: 4.07.02-U · ACCUTOME, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    UBM Plus: Software Package
    Primary DI
    00897826002161
    Version / Model
    4.07.02-U
    Company Name
    ACCUTOME, INC.
    Labeler DUNS
    048792816
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    c303f153-913f-4dcf-89af-8f862bee7b36

    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic

    GMDN Terms

    Code Name
    11389 Ophthalmic ultrasound imaging system

    Identifiers

    Type ID
    Primary 00897826002161

    Premarket Submissions

    Submission Number Supplement Number
    K103471 000