MOUTH GAG, PEDIAT., MALEK, FRAME ONLY


Product Overview

MOUTH GAG, PEDIAT., MALEK, FRAME ONLY
NA - 41-36790


Device Description

A mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 13.0 Centimeter
    • Length: 13.0 Centimeter


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: True

    Sterilization Methods:

  • Moist Heat or Steam Sterilization
    • Moist Heat or Steam Sterilization


    Product Codes

    Code: LRC

    Device Name: Instrument, Ent Manual Surgical

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 874.4420

    Third Party Flag: N

    Medical Specialty: EN


    Device Identifiers

    Device Id: 04546540217042

    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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