BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TALOS® IBF

    DI: B16741522600 · Model: 4-152260 · MEDITECH SPINE, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TALOS® IBF
    Primary DI
    B16741522600
    Version / Model
    4-152260
    Company Name
    MEDITECH SPINE, LLC
    Labeler DUNS
    182698477
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    5
    Public Version Date
    2020-03-23
    Public Version Status
    Update
    Public Device Record Key
    d6847553-9bfe-4615-bcd9-0c06d33dea6f

    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
    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
    60847 Polymeric spinal fusion cage, sterile

    Identifiers

    Type ID
    Primary B16741522600

    Premarket Submissions

    Submission Number Supplement Number
    K090707 000
    K150788 000