CORTAC®

Basic Information

• Brand Name: CORTAC®
• Primary DI: 00650551090366
• Version / Model: 2111TX-36-103-NS
• Catalog Number: 2111TX-36-103-NS
• Company Name: PMT CORPORATION
• Labeler DUNS: 039576871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e1ddb4ed-a774-4039-ae0d-6d46ef03489f

Device Description

SUBDURAL GRID ELECTRODE, STAINLESS STEEL, 36 CONTACT, 6X6, CONTACT #1 RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 3 TOP EXITS, 3 LEADS, 3 TAILS, TOP & BOTTOM ROWS NUMBERED, FULLY CUT HOLES

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: Yes
• 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: No
• 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
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	00650551090366	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K845035	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Contact Diameter 3 Millimeter
Device Size Text, specify			Thickness 0.76 Millimeter