COMBY EEG CAP

Basic Information

• Brand Name: COMBY EEG CAP
• Primary DI: 03858894151950
• Version / Model: Comby EEG Cap/ 22 Ag/AgCl EL.
• Catalog Number: CEC1224752
• Company Name: PAMEL d.o.o.
• Labeler DUNS: 643949162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-16
• Public Version: 1
• Public Version Date: 2022-08-24
• Public Version Status: New
• Public Device Record Key: 14061660-28be-4116-9dda-0de08d2d1adc

Device Description

Comby EEG cap with 22 Ag/AgCl sintered electrodes, size 47-52

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63131	Electroencephalographic electrode cap, reusable	An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap with integrated (and often removable) scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03858894151950	GS1

Premarket Submissions

Submission Number	Supplement Number
K211315	000