BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    BEAR

    DI: B351MV40000 · Model: mV-4000 · Mytamed, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BEAR
    Primary DI
    B351MV40000
    Version / Model
    mV-4000
    Catalog Number
    mV-4000
    Company Name
    Mytamed, Inc.
    Labeler DUNS
    015903922
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-11
    Public Version
    2
    Public Version Date
    2023-11-17
    Public Version Status
    Update
    Public Device Record Key
    dfa68ca1-7bde-44fc-a2dc-fdde7643f0ab
    Distribution End Date
    2020-03-11

    Device Description

    mView Rigid ENT Endoscope, 4.0 x 185mm, 0 Deg.

    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
    ["Moist Heat or Steam Sterilization", "Hydrogen Peroxide", "Peracetic Acid", "High-level Disinfectant"]

    Product Codes

    Code Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    37180 Rigid optical sinoscope

    Identifiers

    Type ID
    Primary B351MV40000

    Premarket Submissions

    Submission Number Supplement Number
    K981751 000