Loading Unit with Polysorb Staples


Product Overview

Loading Unit with Polysorb Staples
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Device Description

A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.


Environmental Conditions

No Data Available


Device Sizes

  • Height: .060 Inch
  • Length: 55 Millimeter
    • Height: .060 Inch
    • Length: 55 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: GDW

    Device Name: Staple, Implantable

    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: 878.4750

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 20884521047577

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521047570

    Package Quantity: 6

    Package Discontinue Date: 5/29/2020 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: CASE


    Device Id: 10884521047570

    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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