Goldtrace Fetal Spiral Electrode (FSE)

GUDID 07340154900010

Neoventa Medical AB

Foetal scalp electrode, spiral

• Primary Device ID: 07340154900010
• NIH Device Record Key: c722fb84-5a09-418a-b7e6-74521881963d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Goldtrace Fetal Spiral Electrode (FSE)
• Version Model Number: CNS000004
• Company DUNS: 776720448
• Company Name: Neoventa Medical AB
• Device Count: 75
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340154900003 [Unit of Use]
GS1	07340154900010 [Package]; Contains: 07340154900027; Package: [2 Units]; In Commercial Distribution
GS1	07340154900027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243291

FDA Product Code

• HGP: Electrode, Circular (Spiral), Scalp And Applicator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-16
• Device Publish Date: 2026-03-06