WISE Cortical Strip (WCS®)

Basic Information

• Brand Name: WISE Cortical Strip (WCS®)
• Primary DI: 18051160960009
• Version / Model: WCS04S10A-00-001
• Company Name: WISE SRL
• Labeler DUNS: 430722016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-19
• Public Version: 1
• Public Version Date: 2024-02-27
• Public Version Status: New
• Public Device Record Key: d535d6ae-bd47-414b-9b08-a9a5348caae3

Device Description

The WISE Cortical Strip (WCS) is a medical device composed of a strip, to be positioned on the surface of the brain, and of a cable, that allows the transmission of the electrical signals to and from IntraOperative Neurophysiological Monitoring (IONM) equipment, to which the WCS is connected by means of an intermediate connecting cable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GYC	Electrode, Cortical	Neurology	882.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32545	Cortical electrode	A sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18051160960009	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K221123	000