N23 CCD System

Basic Information

• Brand Name: N23 CCD System
• Primary DI: 08056600520501
• Version / Model: N23
• Catalog Number: N2360RHNA
• Company Name: NICAL SPA
• Labeler DUNS: 435743877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-11
• Public Version: 1
• Public Version Date: 2023-10-19
• Public Version Status: New
• Public Device Record Key: cef292a0-b768-4157-aa3f-28c35948b2ed

Device Characteristics

• Single Use: No
• 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: 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
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35821	Fluoroscopic x-ray system video image recording unit	An assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a video signal generator, and cabling used to convert the analogue image taken from the output raster of the x-ray image intensifier and to display it on one or more image display monitors [visual display unit (VDU)] for immediate viewing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056600520501	GS1

Premarket Submissions

Submission Number	Supplement Number
K951261	000