Specula, Disposable,4.25mm, 850/pkg


Product Overview

Specula, Disposable,4.25mm, 850/pkg
ADC - 5185


Device Description

A semi-rigid or rigid, plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may be referred to as an ear cannula. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 4.25 Millimeter
    • Length: 4.25 Millimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EPY

    Device Name: Speculum, Ent

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: SU

    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: 878.1800

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 00634782554255

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00634782054465

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: MASTER


    Device Id: 00634782054465

    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


    Device Id: 00634782094515

    Device Type: Unit of Use

    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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