BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LEXER OSTEOTOME

    DI: 00192896096035 · Model: 330-016 · SONTEC INSTRUMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LEXER OSTEOTOME
    Primary DI
    00192896096035
    Version / Model
    330-016
    Catalog Number
    330-016
    Company Name
    SONTEC INSTRUMENTS, INC.
    Labeler DUNS
    040729840
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-08
    Public Version
    1
    Public Version Date
    2019-05-16
    Public Version Status
    New
    Public Device Record Key
    0c3396f4-736a-46e0-9d11-24915caf478c

    Device Description

    LEXER OSTEOTOME PHENOLIC HANDLE

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    Yes
    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", "Dry Heat Sterilization"]

    Product Codes

    Code Name
    HWM Osteotome

    GMDN Terms

    Code Name
    62895 Orthopaedic osteotome handle

    Identifiers

    Type ID
    Primary 00192896096035

    Customer Contacts

    Phone
    800-821-7496
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Length 12 Inch
    Device Size Text, specify 10 Millimeter Tip