BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elite Orthopaedics

    DI: 00816591012113 · Model: K50028 · Elite Orthopaedics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elite Orthopaedics
    Primary DI
    00816591012113
    Version / Model
    K50028
    Catalog Number
    K50028
    Company Name
    Elite Orthopaedics, Inc.
    Labeler DUNS
    803168228
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-17
    Public Version
    1
    Public Version Date
    2023-08-25
    Public Version Status
    New
    Public Device Record Key
    727646b0-d25c-4daa-a6f4-ba67978422c4

    Device Description

    Range Of Motion (ROM) Hinged Knee, X-Large

    Device Characteristics

    Single Use
    Yes
    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
    No
    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 00816591012113