BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CEZANNE II

    DI: 00841732137486 · Model: 018.2510 · CTL MEDICAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CEZANNE II
    Primary DI
    00841732137486
    Version / Model
    018.2510
    Company Name
    CTL MEDICAL CORPORATION
    Labeler DUNS
    080138504
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-10-10
    Public Version
    1
    Public Version Date
    2023-10-18
    Public Version Status
    New
    Public Device Record Key
    541580f9-e287-449a-bd7a-4b3284cb8a98

    Device Description

    CEZANNE-II™ DLIF PEEK Cage, 0Deg., W19 x L40, H10mm

    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
    Yes
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00841732137486

    Premarket Submissions

    Submission Number Supplement Number
    K131981 000