BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ORTHOLOC 3DI

    DI: 00889797101158 · Model: 58A0MPX1L · WRIGHT MEDICAL TECHNOLOGY, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ORTHOLOC 3DI
    Primary DI
    00889797101158
    Version / Model
    58A0MPX1L
    Catalog Number
    58A0MPX1L
    Company Name
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Labeler DUNS
    807201207
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-10
    Public Version
    2
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    4e37b222-011f-4d4b-908b-c17091640c73

    Device Description

    Crosscheck Plate

    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
    Yes
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Radiation Sterilization

    Product Codes

    Code Name
    HRS Plate, fixation, bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00889797101158

    Customer Contacts

    Phone
    +1(800)238-7117
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K152974 000