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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX Medical

    DI: 04961333247387 · Model: EG29-i10c · 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
    04961333247387
    Version / Model
    EG29-i10c
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-07-17
    Public Version
    3
    Public Version Date
    2024-11-18
    Public Version Status
    Update
    Public Device Record Key
    90171887-6829-4bf4-bd04-ecea6ac0dfea

    Device Description

    PENTAX Medical Video Upper GI Scope EG29-i10c

    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
    FDS Gastroscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    17663 Flexible video gastroscope, reusable

    Identifiers

    Type ID
    Direct Marking 04961333237586
    Primary 04961333247387