BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Materialise Personalized Solutions

    DI: 05420060343360 · Model: O-01-0-820000-0011-010 · Materialise NV
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Materialise Personalized Solutions
    Primary DI
    05420060343360
    Version / Model
    O-01-0-820000-0011-010
    Catalog Number
    O-01-0-820000-0011-010
    Company Name
    Materialise NV
    Labeler DUNS
    373139427
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-11
    Public Version
    1
    Public Version Date
    2023-07-19
    Public Version Status
    New
    Public Device Record Key
    6c408494-d96c-46ed-bc9c-6cb3611d88d5

    Device Description

    Acromion Osteotomy Guide and Model

    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
    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
    62249 Custom-made organ/bone anatomy model/surgical guide kit

    Identifiers

    Type ID
    Primary 05420060343360

    Premarket Submissions

    Submission Number Supplement Number
    K112389 000
    K163156 000