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    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALPHALOK Plating System

    DI: 00841731133908 · Model: THP-1270-H · VILEX LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ALPHALOK Plating System
    Primary DI
    00841731133908
    Version / Model
    THP-1270-H
    Catalog Number
    THP-1270-H
    Company Name
    VILEX LLC
    Labeler DUNS
    117502293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-02-12
    Public Version
    1
    Public Version Date
    2024-02-20
    Public Version Status
    New
    Public Device Record Key
    4b9c7cdc-b4d9-44bb-8445-494ce6b481e0

    Device Description

    ANKLE FX Large Hook Plate, 70mm - Half Cannula

    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

    GMDN Terms

    Code Name
    46647 Orthopaedic fixation plate, non-bioabsorbable

    Identifiers

    Type ID
    Primary 00841731133908

    Premarket Submissions

    Submission Number Supplement Number
    K230204 000