BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE

    DI: 04961333240456 · Model: VNL8-J10 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
    Primary DI
    04961333240456
    Version / Model
    VNL8-J10
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-03-13
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    6ad63bc3-7563-4a81-b269-bed5f61f3998

    Device Description

    ULTRASLIM NASOLARYNGOSCOPE (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
    ["Liquid Chemical", "High-level Disinfectant"]

    Product Codes

    Code Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    35462 Flexible video laryngoscope

    Identifiers

    Type ID
    Primary 04961333240456

    Premarket Submissions

    Submission Number Supplement Number
    K172156 000