Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm


Product Overview

Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm
ProSup - TECLGK01


Device Description

A sterile woven/knitted or porous material comprised of a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to desired size/shape. Disposable devices associated with implantation (e.g., introducer needles) may be included.


Environmental Conditions

No Data Available


Device Sizes

  • Width: 15 Centimeter
    • Width: 15 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FTL

    Device Name: Mesh, Surgical, Polymeric

    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: 878.3300

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 10884521177611

    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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