DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE


Product Overview

DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE
Durepair® - 62111


Device Description

A xenograft made from bovine dura mater or bovine pericardium used for the repair or replacement of the dura mater in a recipient during a neurosurgical procedure. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). This dural graft is typically overlaid on the patient's dura and resorbs within 9 to 12 months after surgery. It may be supplied in strips of various sizes and shapes (e.g., square or rectangular) and in a sterile, dry state with treated surfaces.


Environmental Conditions

  • Special Storage Condition, Specify
    • Keep away from heat sources
  • Storage Environment Temperature - Degrees Celsius
    • 30.00
    • 2.00

  • Device Sizes

  • Width: 2.5 Centimeter
  • Length: 2.5 Centimeter
    • Width: 2.5 Centimeter
    • Length: 2.5 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GXQ

    Device Name: Dura Substitute

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: NE

    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: 882.5910

    Third Party Flag: N

    Medical Specialty: NE


    Device Identifiers

    Device Id: 00643169063891

    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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