Disposable non-sterile bite tray (12) for use with trUpoint ARCH


Product Overview

Disposable non
trUpoint ARCH Replacement Kit - MTHF033


Device Description

A non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and neck. It is in the form of an arched frame to which can be attached various components (e.g., mouthpiece, nasion cushion) that non-invasively contact the patient to serve as points of reference, and which is typically attached to a base plate, couch top, or overlay. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Width: 6 Inch
  • Length: 5 Inch
    • Width: 6 Inch
    • Length: 5 Inch


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: IYE

    Device Name: Accelerator, Linear, Medical

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: RA

    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: 892.5050

    Third Party Flag: N

    Medical Specialty: RA


    Device Identifiers

    Device Id: 00841439111802

    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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