Circular Reload For use with Signia Circular Adapters; Medium/Thick


Product Overview

Circular Reload For use with Signia Circular Adapters; Medium/Thick
Tri-Staple 2.0 - SIGCIR25MT


Device Description

A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) and an internal cutting blade designed to be used with a surgical stapler (not included) during endoscopic or open-surgery (e.g., bowel resection to create anastomoses). The unit is designed to deploy the staples (e.g., in a straight or circular row) while the blade cuts the adjacent tissue. This is a single-use device.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 101.00
    • 55.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • N/A
  • Handling Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -20.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 94.00
    • 63.00

  • Device Sizes

  • Outer Diameter: 25 Millimeter
    • Outer Diameter: 25 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: 20884521703800

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521703803

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: PACK_OR_INNER_PACK


    Device Id: 10884521703803

    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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