BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEVEL ONE ORTHOANCHOR

    DI: 00888118098085 · Model: 50-335-14-09 · 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 ORTHOANCHOR
    Primary DI
    00888118098085
    Version / Model
    50-335-14-09
    Company Name
    KLS-Martin L.P.
    Labeler DUNS
    826499238
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-26
    Public Version
    8
    Public Version Date
    2024-01-03
    Public Version Status
    Update
    Public Device Record Key
    ea9dc061-c3ed-4e85-ac62-cb235d83b128

    Device Description

    SCREW, MAXDRIVE, DRILL FREE, 2.0 MM TISSUE COLLAR, 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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    DZE IMPLANT, ENDOSSEOUS, ROOT-FORM

    GMDN Terms

    Code Name
    46536 Orthodontic anchoring screw

    Identifiers

    Type ID
    Primary 00888118098085

    Customer Contacts

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

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify 2.0 X 8 MM THD, TTL=13 MM