System 9 Aseptic Housing, Large


Product Overview

System 9 Aseptic Housing, Large
N/A - 9126120000


Device Description

A cover that functions as a physical barrier between a battery and the sterile battery-powered surgical power tool (e.g., a drill or saw) in which the non-sterile battery is being placed/exchanged prior to or during a surgical procedure. It is typically made from high-grade stainless steel and/or synthetic material and is designed as a flange that fits into/around the slot where the battery is housed (typically in the handle of the power tool). This ensures that no contact is made between the sterile power tool and the person holding it inside the sterile operation field and the non-sterile battery and person loading the battery from outside the sterile field. This is a reusable device.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 75.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • -20.00
  • 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: 07613327482669

    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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