INS 3058 INTERSTIM II eMANUAL US


Product Overview

INS 3058 INTERSTIM II eMANUAL US
INTERSTIM® - 3058


Device Description

An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It consists of an electrode implanted on or in the vicinity of the sacral plexus, a pulse generator with a receiver typically implanted in the abdomen/pelvic region, and an external programmer/transmitter that communicates with the implanted receiver.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 125.00
    • 0.00
  • Storage Environment Temperature - Degrees Celsius
    • 52.00
    • -18.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: EZW

    Device Name: Stimulator, Electrical, Implantable, For Incontinence

    Device Class: 3

    Physical State: N/A

    Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

    Submission Type ID: 2

    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: Y

    Target Area: N/A

    Regulation Number: 876.5270

    Third Party Flag: N

    Medical Specialty: GU


    Device Identifiers

    Device Id: 00613994913654

    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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