BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    LCP

    DI: 10886982100580 · Model: 04.110.340 · SYNTHES (U.S.A.) LP
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LCP
    Primary DI
    10886982100580
    Version / Model
    04.110.340
    Catalog Number
    04110340
    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
    2015-09-14
    Public Version
    6
    Public Version Date
    2023-09-18
    Public Version Status
    Update
    Public Device Record Key
    8dd567c3-aaa5-4f86-b56e-8313e2d0cd31
    Distribution End Date
    2020-07-26

    Device Description

    TI LCP VOLAR COLUMN DISTAL RADIUS PL 9H HEAD/4H SHAFT/RT

    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
    HRS PLATE, FIXATION, BONE
    HWC Screw, fixation, bone

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Secondary H679041103400
    Primary 10886982100580

    Customer Contacts

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

    Premarket Submissions

    Submission Number Supplement Number
    K091644 000