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    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX Medical

    DI: 04961333251834 · Model: OE-B16 · HOYA CORPORATION
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PENTAX Medical
    Primary DI
    04961333251834
    Version / Model
    OE-B16
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-09-20
    Public Version
    1
    Public Version Date
    2023-09-28
    Public Version Status
    New
    Public Device Record Key
    a39fb0c0-5525-49f7-8778-d531157f3621

    Device Description

    PENTAX Medical Cylinder Cleaning Adapter OE-B16

    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
    No
    Has Donation ID
    No

    Sterilization

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

    Product Codes

    Code Name
    PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
    FDS Gastroscope And Accessories, Flexible/Rigid
    FDF Colonoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    64509 Endoscope leak tester tubing

    Identifiers

    Type ID
    Primary 04961333251834

    Premarket Submissions

    Submission Number Supplement Number
    K231249 000