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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Vilex Drill Cannulated

    DI: 00841731114563 · Model: Z402-100-17 · VILEX LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Vilex Drill Cannulated
    Primary DI
    00841731114563
    Version / Model
    Z402-100-17
    Company Name
    VILEX LLC
    Labeler DUNS
    117502293
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-02
    Public Version
    7
    Public Version Date
    2020-05-27
    Public Version Status
    Update
    Public Device Record Key
    6d73880c-65d7-4805-8b57-6275f42e88c0

    Device Description

    Drill, 1.7x100mm QC

    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
    HWC Screw, Fixation, Bone
    HTW Bit, Drill

    GMDN Terms

    Code Name
    47563 Fluted surgical drill bit, single-use, non-sterile

    Identifiers

    Type ID
    Primary 00841731114563

    Premarket Submissions

    Submission Number Supplement Number
    K014154 000
    K991197 000