BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    IntelliSense Drill Technology

    DI: B666MOI30700020 · Model: 1.0 · MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    IntelliSense Drill Technology
    Primary DI
    B666MOI30700020
    Version / Model
    1.0
    Catalog Number
    MOI3070002
    Company Name
    MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
    Labeler DUNS
    078568266
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-05
    Public Version
    1
    Public Version Date
    2022-12-13
    Public Version Status
    New
    Public Device Record Key
    9661aacf-9955-49b4-8f36-0732a92e6093

    Device Description

    IntelliSense Controller and Power Cord

    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
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEY Motor, Surgical Instrument, Ac-Powered

    GMDN Terms

    Code Name
    66243 Bone/joint surgical power tool motorized handpiece/set, electric, reusable

    Identifiers

    Type ID
    Primary B666MOI30700020

    Customer Contacts

    Phone
    3073156403
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K143191 000