BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04961333239498 · Model: EG38-J10UT · HOYA CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    N/A
    Primary DI
    04961333239498
    Version / Model
    EG38-J10UT
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-03
    Public Version
    1
    Public Version Date
    2020-09-11
    Public Version Status
    New
    Public Device Record Key
    277a9995-0cee-4ea5-9421-126880222e7e

    Device Description

    PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT

    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
    Yes
    Sterilization Methods
    ["High-level Disinfectant", "Liquid Chemical"]

    Product Codes

    Code Name
    ODG Endoscopic Ultrasound System, Gastroenterology-Urology
    ITX Transducer, Ultrasonic, Diagnostic

    GMDN Terms

    Code Name
    36951 Flexible ultrasound gastroduodenoscope

    Identifiers

    Type ID
    Direct Marking 04961333239436
    Primary 04961333239498