FDA UDI
In Commercial Distribution
🇺🇸 United States
WCS® Link
DI: 18051160960030
·
Model: WSCC_4CH
·
WISE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WCS® Link
- Primary DI
- 18051160960030
- Version / Model
- WSCC_4CH
- 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
- 6647650c-a7be-451c-8b7c-d445ad552e7f
Device Description
The WCS® Link is a multiple 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.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Hydrogen Peroxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKD | Cable, Electrode | Physical Medicine | 890.1175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35749 | Analytical scalp lead | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18051160960030 | GS1 |
Customer Contacts
- Phone
- +390284962910
- [email protected]