Device
The WCS® Link is a single use cable that interconnects the legally marketed WISE Cortical Strip (WCS®) and a legally marketed IntraOperative Neurophysiological Monitoring
Manufacturer
WISE SPA
WISE SPA
Model: WSCC_4CH-001
DI: 18051160960146
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
The WCS® Link is a single use cable that interconnects the legally marketed WISE Cortical Strip (WCS®) and a legally marketed IntraOperative Neurophysiological Monitoring
(IONM) equipment. The cable is used for transferring brain electrical signals from the WCS® to the IONM equipment (for recording) and/or stimulation pulses from the IONM equipment to the WCS®.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a04015f8-f921-426d-90c8-dd83a62e66e2
Distribution Status:
In Commercial Distribution
DUNS Number:
430722016
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
18051160960146
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35749
Name: Analytical scalp lead
Definition:
A wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.
FDA Product Codes
IKD
Cable, Electrode