BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    NA

    DI: 04250869607643 · Model: 109-015-1028 · Biedermann Motech GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    NA
    Primary DI
    04250869607643
    Version / Model
    109-015-1028
    Catalog Number
    109-015-1028
    Company Name
    Biedermann Motech GmbH & Co. KG
    Labeler DUNS
    320249162
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-06-20
    Public Version
    4
    Public Version Date
    2020-04-06
    Public Version Status
    Update
    Public Device Record Key
    8a7327c9-14b9-4ec8-9846-dd408ce4eaca

    Device Description

    TELIX K Ti Cage 10x28mm 5°

    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
    MAX Intervertebral fusion device with bone graft, lumbar

    GMDN Terms

    Code Name
    38161 Metallic spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 04250869607643

    Premarket Submissions

    Submission Number Supplement Number
    K170890 000