BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FungalBlue

    DI: 00860012465019 · Model: TFX-CTS · ToeFX Inc
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    FungalBlue
    Primary DI
    00860012465019
    Version / Model
    TFX-CTS
    Company Name
    ToeFX Inc
    Labeler DUNS
    202099070
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-12-03
    Public Version
    1
    Public Version Date
    2025-12-11
    Public Version Status
    New
    Public Device Record Key
    27e160ac-7e99-4455-b082-4853cae9c86e

    Device Description

    A temporary skin/nail-marking pen used by clinicians to outline areas of interest on the nail, including regions they plan to assess or debride during management of suspected onychomycosis.

    Device Characteristics

    Single Use
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FZZ Marker, Skin

    GMDN Terms

    Code Name
    61575 Skin marking pen, single-use

    Identifiers

    Type ID
    Primary 00860012465019