BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00190446254546 · Model: 540-65-155 · Encore Medical, L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00190446254546
    Version / Model
    540-65-155
    Company Name
    Encore Medical, L.P.
    Labeler DUNS
    154074504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-28
    Public Version
    1
    Public Version Date
    2019-04-05
    Public Version Status
    New
    Public Device Record Key
    df091f49-bd07-46f4-9b97-53b4d6f1c757

    Device Description

    DISC ULNA 5X155MM RT W/ E+ BRNG

    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
    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
    JDC PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

    GMDN Terms

    Code Name
    33173 Metal-backed elbow ulna prosthesis

    Identifiers

    Type ID
    Primary 00190446254546

    Premarket Submissions

    Submission Number Supplement Number
    K013042 000
    K051975 000