Product Overview

The Mill
NA - 5400700000


Device Description

A non-sterile motorized base unit intended to be used with a disposable cutting cartridge to create particles of bone autografts (i.e., bone harvested from and transplanted into the same patient) for implantation during a bone regeneration or bone grafting procedure. The motor is intended to provide the rotational force required by the cutters in the cartridge to produce the bone particles; it is typically powered by a line-powered surgical power tool control unit. This is a reusable device.


Environmental Conditions

  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: HWE

    Device Name: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 878.4820

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 04546540604095

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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