Mesh Positioning System


Product Overview

Mesh Positioning System
AccuMesh - AMPPCO15X


Device Description

A partially-bioabsorbable, implantable material (e.g., flat sheet) made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.


Environmental Conditions

No Data Available


Device Sizes

  • Outer Diameter: 5.9 Inch
    • Outer Diameter: 5.9 Inch


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: ORQ

    Device Name: Mesh, Surgical, Deployer

    Device Class: 2

    Physical State: manual laparoscopic surgical instrument ;operation handle and deployment section.

    Definition: Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).

    Submission Type ID: 1

    Review Panel: SU

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: abdominal cavity

    Regulation Number: 878.3300

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 10884521174696

    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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