BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    N/A

    DI: 04961333244171 · Model: OF-Z5K · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    N/A
    Primary DI
    04961333244171
    Version / Model
    OF-Z5K
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2018-03-15
    Public Version
    2
    Public Version Date
    2018-07-06
    Public Version Status
    New
    Public Device Record Key
    7aa00f33-320e-4a9e-b6a2-3b43f72109f6

    Device Description

    STANDARD BITE BLOCKS, 3 PIECES

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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", "Sound Waves"]

    Product Codes

    Code Name
    FDS Gastroscope And Accessories, Flexible/Rigid

    GMDN Terms

    Code Name
    10405 Seizure bite block

    Identifiers

    Type ID
    Primary 04961333244171
    Unit of Use 14961333244178

    Premarket Submissions

    Submission Number Supplement Number
    K850020 000