BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MR8 Drill System

    Reg #: 2647346 · FEI: 2647346 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
    Registration Number
    2647346
    FEI Number
    2647346
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ROAD 909, KM. 0.4., BARRIO MARIANA
    City
    HUMACAO
    State
    PR
    ZIP
    00792
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183515

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Motor, Drill, Pneumatic HBB
    Motor, Drill, Electric HBC
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ

    Proprietary Names

    MR8 Drill System Midas Rex MR8 ClearView Tools

    Establishment Types

    Manufacture Medical Device