BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FIBER PANCREATOSCOPE

    DI: 04961333240265 · Model: FCP-9P · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FIBER PANCREATOSCOPE
    Primary DI
    04961333240265
    Version / Model
    FCP-9P
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-12
    Public Version
    1
    Public Version Date
    2018-04-12
    Public Version Status
    New
    Public Device Record Key
    fbaed574-e6d5-4494-86a9-1ce3f6463b57

    Device Description

    FIBEROPTIC CHOLANGIO-PANCREATOSCOPE 1.2C (USED)

    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
    ["Ethylene Oxide", "High-level Disinfectant"]

    Product Codes

    Code Name
    FBN Choledochoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    34939 Flexible fibreoptic choledochoscope

    Identifiers

    Type ID
    Primary 04961333240265