Intelli-C Accessory

Basic Information

• Brand Name: Intelli-C Accessory
• Primary DI: 05713464000336
• Version / Model: 03282000
• Company Name: Nrt - Nordisk Røntgen Teknik A/S
• Labeler DUNS: 307332705
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-21
• Public Version: 2
• Public Version Date: 2022-04-12
• Public Version Status: Update
• Public Device Record Key: 8d8b8e86-a556-443f-b904-2ab53c89954f
• Distribution End Date: 2022-04-11

Device Description

Footrest for the Intelli-C X-ray system to support the patient during table top angulation.

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
OWB	Interventional Fluoroscopic X-Ray System	Radiology	892.1650	2
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37048	Footrest	A device intended to be used to sustain/retain a patient's foot or feet in a desired position. This device will often be considered an accessory to one or more parent devices. It is typically constructed of metal/plastic/rubber and can be attached to, e.g., operating tables/examination tables/treatment chairs.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713464000336	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173631	000