MICROWIRE CORTAC®

Basic Information

• Brand Name: MICROWIRE CORTAC®
• Primary DI: 00650551095620
• Version / Model: 2112-08-096-001-NS
• Catalog Number: 2112-08-096-001-NS
• Company Name: PMT CORPORATION
• Labeler DUNS: 039576871
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 663e5943-fea5-4585-9da5-eda95cb53074

Device Description

SUBDURAL ELECTRODE, LEADS NUMBERED, 96 MICROWIRES, INLINE CONNECTOR, 3 EXITS

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	00650551095620	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082474	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Microwire Diameter 75 Micrometer
Device Size Text, specify			Thickness 0.030 Inch
Device Size Text, specify			Tubing Length 38 Centimeter
Device Size Text, specify			Contact Size 2 Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 58 – 78 Degrees Fahrenheit