BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Comfytopia

    DI: 04719879643947 · Model: FS10 · Comfytopia, Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Comfytopia
    Primary DI
    04719879643947
    Version / Model
    FS10
    Company Name
    Comfytopia, Inc.
    Labeler DUNS
    003944628
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-30
    Public Version
    2
    Public Version Date
    2023-01-10
    Public Version Status
    Update
    Public Device Record Key
    9cae1c8c-6210-434a-bf41-7e6fa80ea545

    Device Description

    BRACOO FS10 Ankle Fulcrum Wrap Comfort Fit Black S/M

    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
    IQI Orthosis, Limb Brace
    ITW Joint, Ankle, External Brace

    GMDN Terms

    Code Name
    66085 Multiple-joint lower limb orthosis

    Identifiers

    Type ID
    Primary 04719879643947