BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GSO GS1 Spacer

    DI: M9935023130 · Model: 502313 · UNIFIED SPINE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    GSO GS1 Spacer
    Primary DI
    M9935023130
    Version / Model
    502313
    Company Name
    UNIFIED SPINE, LLC
    Labeler DUNS
    118413370
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-08
    Public Version
    6
    Public Version Date
    2024-07-01
    Public Version Status
    Update
    Public Device Record Key
    c4b573ed-13b8-4816-a57a-f61f692791fd

    Device Description

    Spacer

    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    MQP Spinal Vertebral Body Replacement Device

    GMDN Terms

    Code Name
    63917 Orthopaedic bone fixation plate spacer

    Identifiers

    Type ID
    Primary M9935023130

    Device Sizes

    Type Value Unit Text
    Height 13 Millimeter