BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ULTRASONIC PROBE

    DI: 04953170143663 · Model: UM-DP20-25R · OLYMPUS MEDICAL SYSTEMS CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ULTRASONIC PROBE
    Primary DI
    04953170143663
    Version / Model
    UM-DP20-25R
    Company Name
    OLYMPUS MEDICAL SYSTEMS CORP.
    Labeler DUNS
    711789789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-10-06
    Public Version
    8
    Public Version Date
    2023-01-16
    Public Version Status
    Update
    Public Device Record Key
    56c257a6-35d0-4715-88a1-39b5c1bf495b

    Device Description

    "N1027530 OLA UM-DP20-25R DUAL PLANE RECO"

    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
    Yes
    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
    Yes
    Sterilization Methods
    ["High-level Disinfectant", "Ethylene Oxide"]

    Product Codes

    Code Name
    ODG Endoscopic ultrasound system, gastroenterology-urology
    FET Endoscopic video imaging system/component, gastroenterology-urology

    GMDN Terms

    Code Name
    64359 Flexible endoscopic ultrasound imaging transducer

    Identifiers

    Type ID
    Primary 04953170143663

    Customer Contacts

    Phone
    +1(800)401-1086
    Email
    [email protected]