BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VSP Orthopedics

    DI: 00816847022477 · Model: Reconstructed Patient Orthopedic Model · 3D SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VSP Orthopedics
    Primary DI
    00816847022477
    Version / Model
    Reconstructed Patient Orthopedic Model
    Company Name
    3D SYSTEMS, INC.
    Labeler DUNS
    085049749
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-11
    Public Version
    3
    Public Version Date
    2023-08-07
    Public Version Status
    Update
    Public Device Record Key
    eb45505d-d90b-4051-afe9-424f85fc67fb

    Device Description

    A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

    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
    MR Unsafe
    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
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    PBF Orthopaedic Surgical Planning And Instrument Guides

    GMDN Terms

    Code Name
    62215 Custom-made organ/bone anatomy model

    Identifiers

    Type ID
    Primary 00816847022477

    Premarket Submissions

    Submission Number Supplement Number
    K190044 000
    K211244 000