INS 37800 ENTERRA II NON-PARYLENE US


Product Overview

INS 37800 ENTERRA II NON
ENTERRA® II - 37800


Device Description

An assembly of devices designed to treat chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis through gastric electrical stimulation (GES) of the lower stomach (antrum). The assembly typically includes a battery-powered implantable pulse generator that produces the electrical stimuli delivered via implantable leads, and an external programmer that enables healthcare personnel to telemetrically modify the GES signal parameters of the pulse generator.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 57.00
    • -34.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 135.00
    • -30.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: LNQ

    Device Name: Intestinal Stimulator

    Device Class: f

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 6

    Review Panel: GU

    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: N/A

    Third Party Flag: N

    Medical Specialty: N/A


    Device Identifiers

    Device Id: 00643169614246

    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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