BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Comfytopia

    DI: 00854194003480 · Model: EP40 · Comfytopia, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Comfytopia
    Primary DI
    00854194003480
    Version / Model
    EP40
    Company Name
    Comfytopia, Inc.
    Labeler DUNS
    003944628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-09
    Public Version
    1
    Public Version Date
    2025-07-17
    Public Version Status
    New
    Public Device Record Key
    8ae6ab34-5a55-4f10-b477-1da00ae93971

    Device Description

    BRACOO EP40 Tennis Elbow Fulcrum Wrap Easy fit w/Cushion PadGray

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    MRI Orthosis, Truncal/Orthosis, Limb

    GMDN Terms

    Code Name
    41459 Wrist/hand orthosis

    Identifiers

    Type ID
    Primary 00854194003480