BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    mytaMed

    DI: B351661010 · Model: 6.61.01 · Mytamed, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    mytaMed
    Primary DI
    B351661010
    Version / Model
    6.61.01
    Catalog Number
    6.61.01
    Company Name
    Mytamed, Inc.
    Labeler DUNS
    015903922
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-15
    Public Version
    4
    Public Version Date
    2025-07-08
    Public Version Status
    Update
    Public Device Record Key
    963a7a97-764b-4c61-88ba-ca7f459e28d8
    Distribution End Date
    2024-12-31

    Device Description

    Farrel Applicator, Triangular, 14cm, 0.9mm

    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
    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 B351661010