BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PENTAX MEDICAL

    DI: 04961333225804 · Model: EPK-i5010 · HOYA CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PENTAX MEDICAL
    Primary DI
    04961333225804
    Version / Model
    EPK-i5010
    Company Name
    HOYA CORPORATION
    Labeler DUNS
    691519705
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    4
    Public Version Date
    2020-05-19
    Public Version Status
    Update
    Public Device Record Key
    2fdcae0e-a762-47fb-bbb1-06c644bc3270

    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
    No

    Product Codes

    Code Name
    PEA Endoscope, accessories, image post-processing for color enhancement
    EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)

    GMDN Terms

    Code Name
    18034 Endoscopic video image processing unit

    Identifiers

    Type ID
    Primary 04961333225804