BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    InkWell Health

    DI: 00860010334584 · Model: LGLKNEE-MTT-3KT · Inkwell Health Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    12

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    Basic Information

    Brand Name
    InkWell Health
    Primary DI
    00860010334584
    Version / Model
    LGLKNEE-MTT-3KT
    Company Name
    Inkwell Health Ltd
    Labeler DUNS
    243295371
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    12
    Record Status
    Published
    Publish Date
    2023-12-20
    Public Version
    1
    Public Version Date
    2023-12-28
    Public Version Status
    New
    Public Device Record Key
    35f5127f-186f-4680-bb96-725da3b3a3c2

    Device Description

    Large Left Knee Medial Temporary Tattoo 3 Month Kit

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FZZ Marker, Skin

    GMDN Terms

    Code Name
    64415 Skin marking guide, single-use

    Identifiers

    Type ID
    Unit of Use 00860010334560
    Primary 00860010334584