BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BEAR

    DI: G043BV34000 · Model: BV3400 · Bear-Ent, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    BEAR
    Primary DI
    G043BV34000
    Version / Model
    BV3400
    Catalog Number
    BV3400
    Company Name
    Bear-Ent, LLC
    Labeler DUNS
    123551586
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-03
    Public Version
    3
    Public Version Date
    2022-04-04
    Public Version Status
    Update
    Public Device Record Key
    cf41b7cd-93a4-4f29-87c2-c587392cb4ce

    Device Description

    Flexible ENT Rhinolaryngoscope, 3.4 x 300mm

    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
    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", "Hydrogen Peroxide", "Peracetic Acid"]

    Product Codes

    Code Name
    EOB Nasopharyngoscope (Flexible Or Rigid)

    GMDN Terms

    Code Name
    35204 Flexible fibreoptic nasopharyngoscope

    Identifiers

    Type ID
    Primary G043BV34000