BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    ProChondrix® Sizer Set

    DI: 00812337021289 · Model: 58161-02 · DSM BIOMEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ProChondrix® Sizer Set
    Primary DI
    00812337021289
    Version / Model
    58161-02
    Company Name
    DSM BIOMEDICAL, INC.
    Labeler DUNS
    131107757
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-06
    Public Version
    5
    Public Version Date
    2023-06-20
    Public Version Status
    Update
    Public Device Record Key
    41606acf-c9ce-41cf-91d6-1146f96b82bb
    Distribution End Date
    2020-06-08

    Device Description

    Single-use disposable orthopedic manual surgical instrument set

    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
    Yes
    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
    HXG Tamp

    GMDN Terms

    Code Name
    44052 Orthopaedic surgical procedure kit, non-medicated, single-use

    Identifiers

    Type ID
    Primary 00812337021289