Articulating Stapler


Product Overview

Articulating Stapler
Roticulator - 017614


Device Description

A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

  • Length: 55 Millimeter
  • Height: 4.8 Millimeter
    • Length: 55 Millimeter
    • Height: 4.8 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: 20884521047706

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884521047709

    Package Quantity: 3

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884521047709

    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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