BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-Fit Offloader Right

    DI: 00859718007258 · Model: FLEORK0001 – Offloader right · Emsi
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Pro-Fit Offloader Right
    Primary DI
    00859718007258
    Version / Model
    FLEORK0001 – Offloader right
    Company Name
    Emsi
    Labeler DUNS
    932471881
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-21
    Public Version
    1
    Public Version Date
    2023-03-29
    Public Version Status
    New
    Public Device Record Key
    d632b9b0-d7d9-4402-ab78-aeacdc82b059

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITQ Joint, Knee, External Brace

    GMDN Terms

    Code Name
    41065 Knee support orthosis

    Identifiers

    Type ID
    Primary 00859718007258