RADIANCE

Basic Information

• Brand Name: RADIANCE
• Primary DI: 00818089020235
• Version / Model: 90R0114
• Company Name: Nds Surgical Imaging LLC
• Labeler DUNS: 081712583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-06
• Public Version: 6
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: db98e929-df52-4907-bdde-0e51f859d2ed

Device Description

RADIANCE ULTRA 32", TRUCOLOR, PRIMARY ONLY, SC-WU32-G1507

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: 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36612	Image display unit, colour	An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This group of devices is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818089020235	GS1

Customer Contacts

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