Sinuscope 4.0mm, 70 Wide Angle


Product Overview

Sinuscope 4.0mm, 70 Wide Angle
SINUSCOPE - 8856-WA


Device Description

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Angle: 70 degree
  • Outer Diameter: 4.0 Millimeter
    • Angle: 70 degree
    • Outer Diameter: 4.0 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EOB

    Device Name: Nasopharyngoscope (Flexible Or Rigid)

    Device Class: 2

    Physical State: N/A

    Definition: If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

    Submission Type ID: 1

    Review Panel: EN

    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: 874.4760

    Third Party Flag: Y

    Medical Specialty: EN


    Device Identifiers

    Device Id: 04961333230570

    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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