BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX

    DI: 04961333070459 · Model: OF-B115 · HOYA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PENTAX
    Primary DI
    04961333070459
    Version / Model
    OF-B115
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-07
    Public Version
    7
    Public Version Date
    2020-11-19
    Public Version Status
    Update
    Public Device Record Key
    817b5a44-c5d4-4075-adb3-0e744fa213cf

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["High-level Disinfectant", "Ethylene Oxide", "Sound Waves", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    FDT duodenoscope and accessories, flexible/rigid

    GMDN Terms

    Code Name
    60417 Luer/non-ISO80369-standardized linear connector, reusable

    Identifiers

    Type ID
    Primary 04961333070459

    Premarket Submissions

    Submission Number Supplement Number
    K963056 000