BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Rheo Knee

    DI: 05690967595425 · Model: RKN130203 · OSSUR AMERICAS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rheo Knee
    Primary DI
    05690967595425
    Version / Model
    RKN130203
    Catalog Number
    RKN130203
    Company Name
    OSSUR AMERICAS, INC.
    Labeler DUNS
    139280028
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-05-16
    Public Version
    2
    Public Version Date
    2021-03-09
    Public Version Status
    Update
    Public Device Record Key
    3c10ad8e-c86b-42e0-983d-284f30edabc6
    Distribution End Date
    2020-09-28

    Device Description

    RHEO KNEE 3 Trials

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ISW ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL

    GMDN Terms

    Code Name
    64721 Mechatronic external knee prosthesis

    Identifiers

    Type ID
    Primary 05690967595425