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Product Overview

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GIA Premium - 030424L


Device Description

A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecologic, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the expeditious transection/resection of tissues and creation of anastomoses; it may also be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) 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

  • Handling Environment Temperature - Degrees Fahrenheit
    • 130.00
    • N/A

  • Device Sizes

  • Length: 50 Millimeter
  • Height: 3.8 Millimeter
    • Length: 50 Millimeter
    • Height: 3.8 Millimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: FHM

    Device Name: Apparatus, Suturing, Stomach And Intestinal

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: N

    Target Area: N/A

    Regulation Number: 878.4800

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 20884523007098

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10884523007091

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: CASE


    Device Id: 10884523007091

    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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