Subdural Electrode

Basic Information

• Brand Name: Subdural Electrode
• Primary DI: 00841823102799
• Version / Model: FG48G-SP10X-0C6
• Catalog Number: FG48G-SP10X-0C6
• Company Name: Ad-Tech Medical Instrument Corporation
• Labeler DUNS: 174813410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: 2ed2221a-727d-4e34-9e94-526147884c01

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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	00841823102799	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053363	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: To be stored and used within typical hospital/office room ambient temperature and humidity conditions