NICO

Basic Information

• Brand Name: NICO
• Primary DI: M678NN90100
• Version / Model: NN-9010
• Catalog Number: NN-9010
• Company Name: SUNOPTIC TECHNOLOGIES LLC
• Labeler DUNS: 094586898
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-27
• Public Version: 1
• Public Version Date: 2025-04-04
• Public Version Status: New
• Public Device Record Key: 316b33e9-4c2b-4ed9-aab4-b6ab454a69a7

Device Description

Replacement Xenon Lamp Module for NICO Myriad-LX, Xenon Light Source, Part Number NN-7064, Model Tx350A

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65951	Procedural cold light bulb	An electrically-powered device in the form of a light bulb designed to be integrated into an appropriate light source unit (not included) to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during surgery, examination, and/or endoscopy. It is a replaceable component of the assembly and does not include a light switch.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M678NN90100	HIBCC