BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEVEL ONE NEURO, STERILE

    DI: 00888118106643 · Model: 25-153-14-71 · KLS-Martin L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LEVEL ONE NEURO, STERILE
    Primary DI
    00888118106643
    Version / Model
    25-153-14-71
    Company Name
    KLS-Martin L.P.
    Labeler DUNS
    826499238
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-23
    Public Version
    7
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    6df5ae68-200a-478f-8c56-4351390c5312

    Device Description

    PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V

    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
    JEY PLATE, BONE

    GMDN Terms

    Code Name
    46642 Craniofacial fixation plate, non-bioabsorbable, non-customized

    Identifiers

    Type ID
    Primary 00888118106643

    Customer Contacts

    Phone
    +1(904)641-7746
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 4 HOLE, 22 MM, T=0.35 MM