BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Flex-Tone

    DI: 00856817005659 · Model: FT660 · AXELGAARD MANUFACTURING CO., LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Flex-Tone
    Primary DI
    00856817005659
    Version / Model
    FT660
    Company Name
    AXELGAARD MANUFACTURING CO., LTD.
    Labeler DUNS
    150959401
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-03-31
    Public Version
    5
    Public Version Date
    2022-03-16
    Public Version Status
    Update
    Public Device Record Key
    fcf909e3-ca25-4b55-bb1d-46946c0ea3b6
    Distribution End Date
    2018-09-03

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    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
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Primary 00856817005659

    Customer Contacts

    Phone
    760-451-8000
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K132422 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    41 – 80.6 Degrees Fahrenheit