Intelli-C Accessory

Basic Information

• Brand Name: Intelli-C Accessory
• Primary DI: 05713464000381
• Version / Model: 03283000
• 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: 2019-02-19
• Public Version: 2
• Public Version Date: 2022-04-12
• Public Version Status: Update
• Public Device Record Key: 30cdc566-27f5-4179-b906-47a4aa107627
• Distribution End Date: 2022-04-11

Device Description

Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioning/support of the patient during angulation towards the Trendelenburg position.

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
40900	Radiological arm/leg positioner	A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713464000381	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173631	000