BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    mytaMed

    DI: B351MV40450 · Model: mV-4045 · Mytamed, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    mytaMed
    Primary DI
    B351MV40450
    Version / Model
    mV-4045
    Catalog Number
    mV-4045
    Company Name
    Mytamed, Inc.
    Labeler DUNS
    015903922
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    0f2e7296-5d7f-439e-bcbe-b961f9539a67

    Device Description

    mytaView ac Rigid ENT Endoscope, 4.0 x 185mm, 45 degree

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["High-level Disinfectant", "Peracetic Acid", "Hydrogen Peroxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    37180 Rigid optical sinoscope

    Identifiers

    Type ID
    Primary B351MV40450

    Premarket Submissions

    Submission Number Supplement Number
    K981751 000