BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ComfyHealth

    DI: 04719879646498 · Model: TP33 · 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
    04719879646498
    Version / Model
    TP33
    Company Name
    Comfy Health Group Co., Ltd.
    Labeler DUNS
    658202517
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-02-20
    Public Version
    2
    Public Version Date
    2025-07-08
    Public Version Status
    Update
    Public Device Record Key
    3237bcc0-3e69-4afa-8c25-0e83374e184d

    Device Description

    BRACOO TP33 Thumb Fulcrum wrap Ergonomic Stabilizer Black

    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 04719879646498