NA

Basic Information

• Brand Name: NA
• Primary DI: 04582275270037
• Version / Model: M339 DME CARBON CL
• Company Name: KONAN MEDICAL USA, INC.
• Labeler DUNS: 788439219
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: d679f809-ee0b-4afe-85e8-0092f303b7eb

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: No
• 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
45576	Visual evoked-potential electrode	An electrical conductor intended to be placed on the skin to record changes in the electrical potential for the purpose of measuring visual evoked responses. It is typically placed on the forehead of the patient at strategic points around the eyes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582275270037	GS1