BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ENDO-GATOR

    DI: 04961333243006 · Model: EGP-009 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ENDO-GATOR
    Primary DI
    04961333243006
    Version / Model
    EGP-009
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-12
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    cb735af8-d93d-4a69-8c4e-390561c16029
    Distribution End Date
    2018-04-12

    Device Description

    FOOTSWITCH FOR EGP-100P

    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
    OCX Endoscopic Irrigation/Suction System

    GMDN Terms

    Code Name
    36336 Foot-switch, electrical

    Identifiers

    Type ID
    Primary 04961333243006

    Premarket Submissions

    Submission Number Supplement Number
    K060962 000