BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fortilink Cages with TiPlus Technology

    DI: 08720246787818 · Model: Fortilink®-L · Baat Medical Products B.V.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fortilink Cages with TiPlus Technology
    Primary DI
    08720246787818
    Version / Model
    Fortilink®-L
    Catalog Number
    67-L-1845-15-12L
    Company Name
    Baat Medical Products B.V.
    Labeler DUNS
    413205480
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-03
    Public Version
    1
    Public Version Date
    2021-12-13
    Public Version Status
    New
    Public Device Record Key
    92b6d1df-8fd1-45c9-8120-81a688ee5bbf

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 08720246787818

    Premarket Submissions

    Submission Number Supplement Number
    K201453 000