Fetal Spiral Electrode For Corometrics


Product Overview

Fetal Spiral Electrode For Corometrics
Vital Signs - 7000AAO


Device Description

A sterile electrical conductor designed to transmit electric signals from the foetal scalp to an intrapartum monitor. The device is a spiralled (either single- or double-helix) metallic electrode with a sharp tip that is directly inserted into the foetal scalp with a screwing action; and an adaptor cable that may include a transducer. The electrode penetrates into the scalp up to 2.5 mm (0.1 inch); it is usually inserted with a dedicated applicator that may be included. The electrode is typically used to monitor a foetal physiologic signal (e.g., heart rate) during labour (intrapartum) after rupture of the amniotic sac. This is a single-use device.


Environmental Conditions

  • Storage Environment Temperature - Degrees Fahrenheit
    • 100.00
    • 41.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: True

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: HGP

    Device Name: Electrode, Circular (Spiral), Scalp And Applicator

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: OB

    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: 884.2675

    Third Party Flag: Y

    Medical Specialty: OB


    Device Identifiers

    Device Id: 50885403248960

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 10885403248962

    Package Quantity: 50

    Package Discontinue Date: 3/31/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 10885403248962

    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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