Maryland Jaw Sealer/Divider


Product Overview

Maryland Jaw Sealer/Divider
N/A - LF1737


Device Description

A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a previously used single-use device that has been processed for an additional single-use patient application.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 90.00
    • 15.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -18.00

  • Device Sizes

  • Diameter: 5.0 Millimeter
  • Length: 37.0 Centimeter
    • Diameter: 5.0 Millimeter
    • Length: 37.0 Centimeter


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: NUJ

    Device Name: Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

    Device Class: 2

    Physical State: N/A

    Definition: Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

    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: N

    Target Area: N/A

    Regulation Number: 878.4400

    Third Party Flag: N

    Medical Specialty: SU


    Device Identifiers

    Device Id: 57613327375812

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 07613327375817

    Package Quantity: 6

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: case


    Device Id: 07613327375817

    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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