BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DJO SURGICAL

    DI: 00190446844532 · Model: 355-02-004 · Encore Medical, L.P.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DJO SURGICAL
    Primary DI
    00190446844532
    Version / Model
    355-02-004
    Company Name
    Encore Medical, L.P.
    Labeler DUNS
    154074504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-07-03
    Public Version
    1
    Public Version Date
    2024-07-11
    Public Version Status
    New
    Public Device Record Key
    6b1711b2-634c-45ab-bd50-6afb4bebe859

    Device Description

    EMP Rev Knee, Symmetric Cone, Femoral, LG

    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
    Yes
    MRI Safety
    MR Conditional
    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
    MBH PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
    JWH PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

    GMDN Terms

    Code Name
    48067 Knee arthroplasty wedge

    Identifiers

    Type ID
    Primary 00190446844532

    Premarket Submissions

    Submission Number Supplement Number
    K240324 000