Product Overview

INSTRUMENT BATTERY
NA - 6000-006-000


Device Description

A non-rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The device includes terminals and may include a case. The size, shape, and chemical composition of the device should be specified according to the requirements in "IEC 60086-1 Primary batteries - Part 1: General", or the latest version of this standard.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 70.00
    • 10.00
  • Handling Environment Temperature - Degrees Celsius
    • 40.00
    • -20.00
  • Special Storage Condition, Specify
    • KEEP DRY
  • Special Storage Condition, Specify
    • DO NOT EXPOSE TO SUNLIGHT
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 106.00
    • 50.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 70.00
    • 10.00
  • Storage Environment Temperature - Degrees Celsius
    • 40.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OLO

    Device Name: Orthopedic Stereotaxic Instrument

    Device Class: 2

    Physical State: Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.

    Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

    Submission Type ID: 1

    Review Panel: OR

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Orthopedic joints and spinal procedures where tracking of instrumentation is desired.

    Regulation Number: 882.4560

    Third Party Flag: N

    Medical Specialty: NE


    Code: HAW

    Device Name: Neurological Stereotaxic Instrument

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.4560

    Third Party Flag: N

    Medical Specialty: NE


    Device Identifiers

    Device Id: 04546540245045

    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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