BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    COLOSSEUM

    DI: 00889095977233 · Model: 156.910 · GLOBUS MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    COLOSSEUM
    Primary DI
    00889095977233
    Version / Model
    156.910
    Company Name
    GLOBUS MEDICAL, INC.
    Labeler DUNS
    139105691
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-12-25
    Public Version
    2
    Public Version Date
    2020-02-24
    Public Version Status
    Update
    Public Device Record Key
    a06e2102-09b0-458b-ac57-16364ad98a7e

    Device Description

    COLOSSEUM Mesh, 25x30mm, 40mm

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    PLR Spinal vertebral body replacement device - Cervical
    MQP Spinal vertebral body replacement device

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00889095977233

    Premarket Submissions

    Submission Number Supplement Number
    K190147 000

    Device Sizes

    Type Value Unit Text
    Height 40 Millimeter
    Depth 25 Millimeter
    Width 30 Millimeter