Product Overview

Block
MEDPOR - 6338


Device Description

A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Width: 38.0 Millimeter
  • Length: 63.0 Millimeter
  • Thickness: 3.0 Millimeter
    • Width: 38.0 Millimeter
    • Length: 63.0 Millimeter
    • Thickness: 3.0 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FWP

    Device Name: Prosthesis, Chin, Internal

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    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: Y

    Target Area: N/A

    Regulation Number: 878.3550

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 07613252083498

    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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