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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX Medical

    DI: 04961333251049 · Model: OS-H5 · HOYA CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PENTAX Medical
    Primary DI
    04961333251049
    Version / Model
    OS-H5
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-11
    Public Version
    1
    Public Version Date
    2024-03-19
    Public Version Status
    New
    Public Device Record Key
    e712b351-e265-413d-9525-4a13dca0881f

    Device Description

    PENTAX Water Bottle Assembly

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    PEA Endoscope, accessories, image post-processing for color enhancement

    GMDN Terms

    Code Name
    61156 Endoscopic irrigation/distension bottle

    Identifiers

    Type ID
    Direct Marking 04961333251025
    Primary 04961333251049