Leg Attachment Pad for Corometrics™ Fetal Scalp Electrode Cable
N/A - 2464AAO
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
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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 IdentifiersDevice Id: 20885403252201
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403252204
Package Quantity: 50
Package Discontinue Date: 3/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Box
Device Id: 10885403252204
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