FDA.reportPublic FDA data

Foetal scalp electrode, spiral

Definition
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.
GUDID devices
39
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00814247020741Goldtrace OneCLINICAL INNOVATIONS, LLCCNS0000082016-09-01
00814247021199FSECLINICAL INNOVATIONS, LLCFSE-025S2023-09-27
00815277027243CuraplexBOUND TREE MEDICAL, LLC533-MS-25058EA2016-12-16
00817617022758CuraplexBOUND TREE MEDICAL, LLC533-MS-25058EA2017-02-06
07340154900027Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABCNS0000042026-03-06
10190752142176Vital Signs™AirLife Finland Oy7000AAO2020-12-15
10192253021158KendallCardinal Health 200, LLC314813962021-02-23
10192253040500KendallCardinal Health 200, LLC314795492022-05-27
10884521081123KendallCardinal Health, Inc.400000322016-09-24
10884527004911KendallCardinal Health, Inc.314795492016-09-24
10885403248962Vital SignsCarefusion Finland 320 Oy7000AAO2016-09-14
10885403252204N/ACarefusion Finland 320 Oy2464AAO2016-10-17
10889483588406Vital Signs™AirLife Finland Oy7000AAO2025-03-31
07340154900010Goldtrace Fetal Spiral Electrode (FSE)Neoventa Medical ABCNS0000042026-03-06
20889483588403Vital Signs™AirLife Finland Oy7000AAO2025-03-31
50885403248960Vital SignsCarefusion Finland 320 Oy7000AAO2016-09-14
00814247021205FSE CablesCLINICAL INNOVATIONS, LLCFSE-001C2023-09-27
10814247021196FSECLINICAL INNOVATIONS, LLCFSE-025S2023-09-27
50192253021156KendallCardinal Health 200, LLC314813962021-02-23
50190752142174Vital Signs™Vyaire Medical Oy7000AAO2020-12-15
20884521081120KendallCardinal Health, Inc.400000322016-09-24
20884527004918KendallCardinal Health, Inc.314795492016-09-24
20885403252201N/ACarefusion Finland 320 Oy2464AAO2016-10-17
20884838007431Fetal MeasurementsPhilips Medical Systems HsgFETAL SPIRAL ELECTRODE2016-11-08
00817617021850CuraplexBOUND TREE MEDICAL, LLC533-MS-25058EA2017-02-06
00815277025447CuraplexBOUND TREE MEDICAL, LLC301-181EA2016-12-14
00815277027236CuraplexBOUND TREE MEDICAL, LLC533-MS-25058EA2016-12-16
00815277027250CuraplexBOUND TREE MEDICAL, LLC533-MS-25060EA2016-12-14
00814247020505Spiral Fetal Scalp ElectrodeCLINICAL INNOVATIONS, LLCCNS0000042016-09-01
00814247020512FSE CablesCLINICAL INNOVATIONS, LLCSBT-70102016-09-01
00814247020529FSE CablesCLINICAL INNOVATIONS, LLCSBT-70112016-09-01
00814247020536FSE CablesCLINICAL INNOVATIONS, LLCSBT-70122016-09-01
00814247020543FSE CablesCLINICAL INNOVATIONS, LLCSBT-70142016-09-01
00814247020550FSE CablesCLINICAL INNOVATIONS, LLCSBT-70152016-09-01
00814247020567FSE CablesCLINICAL INNOVATIONS, LLCSBT-70162016-09-01
00814247020574FSE CablesCLINICAL INNOVATIONS, LLCSBT-70172016-09-01
00814247020581FSE CablesCLINICAL INNOVATIONS, LLCSBT-70182016-09-01
00814247020598FSE CablesCLINICAL INNOVATIONS, LLCSBT-70192016-09-01
20814247020745Goldtrace OneCLINICAL INNOVATIONS, LLCCNS0000082016-09-01