BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Mirror™

    DI: M543100320 · Model: 100320 · CAYENNE MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Mirror™
    Primary DI
    M543100320
    Version / Model
    100320
    Company Name
    CAYENNE MEDICAL, INC.
    Labeler DUNS
    606719685
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2015-10-23
    Public Version
    6
    Public Version Date
    2025-05-30
    Public Version Status
    Update
    Public Device Record Key
    0f4e34af-5123-4d44-80e9-3dadd36397fc
    Distribution End Date
    2021-08-16

    Device Description

    Tibial insert, flat (LM/RL-48x8mm)

    Device Characteristics

    Single Use
    Yes
    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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
    HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

    GMDN Terms

    Code Name
    48070 Unicondylar knee insert

    Identifiers

    Type ID
    Primary M543100320