BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    BEAR

    DI: G043661010 · Model: 6.61.01 · Bear-Ent, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    BEAR
    Primary DI
    G043661010
    Version / Model
    6.61.01
    Catalog Number
    6.61.01
    Company Name
    Bear-Ent, LLC
    Labeler DUNS
    123551586
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-03
    Public Version
    1
    Public Version Date
    2022-05-11
    Public Version Status
    New
    Public Device Record Key
    a04998be-e911-4e2b-a75c-cb7aeb5adef6

    Device Description

    Farrel Applicator, Triangular Tip, 14cm

    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
    Yes
    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
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    KCJ Applicator, Ent

    GMDN Terms

    Code Name
    64011 General-purpose absorbent tip applicator/swab, reusable

    Identifiers

    Type ID
    Primary G043661010