FSE Cables

GUDID 00814247020581

Cables to FSE

CLINICAL INNOVATIONS, LLC

Foetal scalp electrode, spiral

• Primary Device ID: 00814247020581
• NIH Device Record Key: dc36e0c3-be8c-4564-a2b7-0c4894169dd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FSE Cables
• Version Model Number: SBT-7018
• Company DUNS: 809524291
• Company Name: CLINICAL INNOVATIONS, LLC
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814247020581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030691

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-01

On-Brand Devices [FSE Cables]

• 00814247020598: Cables to FSE
• 00814247020581: Cables to FSE
• 00814247020574: Cables to FSE
• 00814247020567: Cables to FSE
• 00814247020550: Cables to FSE
• 00814247020543: Cables to FSE
• 00814247020536: Cables to FSE
• 00814247020529: Cables to FSE
• 00814247020512: Cables to FSE
• 00814247021205: DECG Reusable Legplate Adapter Cable