BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VIDEO DUODENOSCOPE

    DI: 04961333232956 · Model: ED34-I10T-US · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VIDEO DUODENOSCOPE
    Primary DI
    04961333232956
    Version / Model
    ED34-I10T-US
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-12
    Public Version
    3
    Public Version Date
    2019-01-23
    Public Version Status
    Update
    Public Device Record Key
    dec845dd-2ef2-4eaf-889b-9835bc0422e4

    Device Description

    C.A.P. HD DUODENOSCOPE (US NEW)

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Ethylene Oxide", "High-level Disinfectant"]

    Product Codes

    Code Name
    FDT Duodenoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    36112 Flexible video duodenoscope, reusable

    Identifiers

    Type ID
    Primary 04961333232956

    Premarket Submissions

    Submission Number Supplement Number
    K163614 000