Product Overview

FRAMELESS GUIDE
NA - 6000-022-000


Device Description

A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 65.00
    • 20.00
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 10.00

  • Device Sizes

  • Diameter: 24.0 Millimeter
  • Length: 48.0 Millimeter
    • Diameter: 24.0 Millimeter
    • Length: 48.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    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: 04546540245168

    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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