BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    SynFix-LR

    DI: 10705034722382 · Model: 03.802.243 · SYNTHES (U.S.A.) LP
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SynFix-LR
    Primary DI
    10705034722382
    Version / Model
    03.802.243
    Catalog Number
    03802243
    Company Name
    SYNTHES (U.S.A.) LP
    Labeler DUNS
    832637081
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-31
    Public Version
    4
    Public Version Date
    2020-09-17
    Public Version Status
    Update
    Public Device Record Key
    cd1bb735-f85a-46ed-b2ad-66abab6dce48
    Distribution End Date
    2020-09-17

    Device Description

    13.5MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR

    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
    No
    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

    Product Codes

    Code Name
    FZX Guide, surgical, instrument

    GMDN Terms

    Code Name
    47815 Orthopaedic implant aiming/guiding block, reusable

    Identifiers

    Type ID
    Direct Marking 07611819310957
    Secondary H981038022430
    Primary 10705034722382

    Customer Contacts

    Phone
    +1(800)255-2500
    Email
    [email protected]