Home GUDID 07340154900027 Goldtrace Fetal Spiral Electrode (FSE)
Primary DI 07340154900027
Brand Goldtrace Fetal Spiral Electrode (FSE)
Company Neoventa Medical AB
Model CNS000004
Published 2026-03-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name HGP Electrode, Circular (Spiral), Scalp And Applicator
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HGP Electrode, Circular (Spiral), Scalp And Applicator Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07340154900010 Package GS1 2 In Commercial Distribution 07340154900027 Primary GS1 0 07340154900003 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07340154900010 07340154900010 7340154900010 07340154900027 07340154900027 7340154900027 07340154900003 07340154900003 7340154900003
GMDN Terms# Term, Definition table Term Definition Foetal scalp electrode, spiral 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.
Regulatory Flags# DUNS number 776720448 Device count 75 Lot or batch true Manufacturing date on label true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07340154900010 Goldtrace Fetal Spiral Electrode (FSE) CNS000004 2026-03-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07340154900010 Goldtrace Fetal Spiral Electrode (FSE) Neoventa Medical AB HGP 2026-03-06 10889483588406 Vital Signs™ AirLife Finland Oy HGP 2025-03-31 20889483588403 Vital Signs™ AirLife Finland Oy HGP 2025-03-31 05055270977113 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 05055270977144 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 05055270977137 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 05055270977168 Rocket ROCKET MEDICAL PLC HGP 2023-10-24 00814247021199 FSE CLINICAL INNOVATIONS, LLC HGP 2023-09-27 10814247021196 FSE CLINICAL INNOVATIONS, LLC HGP 2023-09-27 00814247021205 FSE Cables CLINICAL INNOVATIONS, LLC HGP 2023-09-27 10192253040500 Kendall Cardinal Health 200, LLC HGP 2022-05-27 10192253021158 Kendall Cardinal Health 200, LLC HGP 2021-02-23 50192253021156 Kendall Cardinal Health 200, LLC HGP 2021-02-23 10190752142176 Vital Signs™ AirLife Finland Oy HGP 2020-12-15 50190752142174 Vital Signs™ Vyaire Medical Oy HGP 2020-12-15 10192253020977 Kendall Cardinal Health 200, LLC HGP 2020-10-30 50192253020975 Kendall Cardinal Health, Inc. HGP 2020-10-30 B510FM30001 ADVANCED FETAL MONITOR ADVANCED INSTRUMENTATIONS, INC. HGP 2020-04-16 00884838007475 NA Philips Medical Systems Hsg HGP 2017-07-24 00884838007468 NA Philips Medical Systems Hsg HGP 2017-03-14 00884838007451 Fetal Measurements Philips Medical Systems Hsg HGP 2017-01-16 20884838007431 Fetal Measurements Philips Medical Systems Hsg HGP 2016-11-08 10885403252204 N/A Carefusion Finland 320 Oy HGP 2016-10-17 20885403252201 N/A Carefusion Finland 320 Oy HGP 2016-10-17 10884521081123 Kendall Cardinal Health, Inc. HGP 2016-09-24 10884527004911 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884527002822 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884521081120 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884527004918 Kendall Cardinal Health, Inc. HGP 2016-09-24 20884527002815 Kendall Cardinal Health, Inc. HGP 2016-09-24