BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    IRRIGATOR/INSUFFLATOR

    DI: 04961333241781 · Model: 100551P · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    IRRIGATOR/INSUFFLATOR
    Primary DI
    04961333241781
    Version / Model
    100551P
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2018-03-13
    Public Version
    3
    Public Version Date
    2018-10-08
    Public Version Status
    Update
    Public Device Record Key
    a9d4e59a-d2c2-4773-b619-257d9231e926
    Distribution End Date
    2018-06-21

    Device Description

    CO2 TUBING, EGA-501P, 10/PKG

    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
    No

    Product Codes

    Code Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    41617 Gastrointestinal endoscopic insufflator

    Identifiers

    Type ID
    Primary 04961333241781
    Unit of Use 14961333241788

    Premarket Submissions

    Submission Number Supplement Number
    K093665 000