Dural Sealant System,


Product Overview

Dural Sealant System,
Duraseal - 20-2010


Device Description

An implanted bioabsorbable material (e.g., solution, gel, spray, patch) intended to be applied to a defect in the dura mater, possibly as an adjunct to standard methods of closure (e.g., suturing), to prevent cerebrospinal fluid (CSF) leakage during healing. The material primarily consists of synthetic polymers that subsequently form adhesive bonds with the dura mater and eventually degrade and are absorbed. After application, this device cannot be reused.


Environmental Conditions

  • Handling Environment Temperature - Degrees Fahrenheit
    • 77.00
    • N/A

  • Device Sizes

  • Nominal inner volume content 5 Millimeter;
    • Nominal inner volume content 5 Millimeter;


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NQR

    Device Name: Sealant, Dural

    Device Class: 3

    Physical State: N/A

    Definition: Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.

    Submission Type ID: 2

    Review Panel: NE

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: Y

    Unclassified Reason: N/A

    Implant Flag: Y

    Target Area: N/A

    Regulation Number: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 10884521056411

    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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