BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ComfyHealth

    DI: 04719879640281 · Model: WS11 · Comfy Health Group Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    ComfyHealth
    Primary DI
    04719879640281
    Version / Model
    WS11
    Company Name
    Comfy Health Group Co., Ltd.
    Labeler DUNS
    658202517
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-18
    Public Version
    3
    Public Version Date
    2025-07-09
    Public Version Status
    Update
    Public Device Record Key
    ebb5bfe6-51fc-4fef-b692-18fa5110c8e5
    Distribution End Date
    2022-11-18

    Device Description

    BRACOO WS11 Wrist Fulcrum Wrap Easyfit w/Splint

    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
    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 04719879640281