Intelli-C Accessory

GUDID 05713464000541

A set of three adjustable straps with quick-fit Velcro fastenings restrains the patient in a fixed position for the Intelli-C X-ray system

Nrt - Nordisk Røntgen Teknik A/S

Radiological arm/leg positioner

• Primary Device ID: 05713464000541
• NIH Device Record Key: 161cc3f2-2f22-4dd2-a18c-f365f3feb9e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intelli-C Accessory
• Version Model Number: 21320012
• Company DUNS: 307332705
• Company Name: Nrt - Nordisk Røntgen Teknik A/S
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4586283500
• Email: nrt@nrtxray.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713464000541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173631

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-01-21

On-Brand Devices [Intelli-C Accessory]

• 05713464000541: A set of three adjustable straps with quick-fit Velcro fastenings restrains the patient in a fix
• 05713464000404: Radiation shield, Below Table for the Intelli-C X-ray system. A lead curtain for protection agai
• 05713464000381: Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioning/sup
• 05713464000343: A pair of Hand Grips for the Intelli-C X-ray system to be fixed freely along both sides of the t
• 05713464000336: Footrest for the Intelli-C X-ray system to support the patient during table top angulation.
• 05713464000329: Table Top support, CPR for the Intelli-C X-ray system. A height adjustable device intended to gi
• 05713464000312: Mattress, 3 cm for the Intelli-C X-ray system, for optimizing patient comfort when lying on tabl
• 05713464000459: A removable table top for the Intelli-C X-ray system, left side suspended. The removable table e
• 05713464000442: A removable table top for the Intelli-C X-ray system, right side suspended. The removable table
• 05713464000435: IV Stand for the Intelli-C X-ray system to be fixed in any position along the patient table to a
• 05713464000428: Side Bar for the Intelli-C X-ray system. A long side bar to be fixed in any position along the t
• 05713464000398: Arm support for the Intelli-C X-ray system. An adjustable arm support intended mainly for use du
• 05713464000350: A long mattress for the Intelli-C X-ray system with a strap, for fixating the mattress when the
• 05713464000305: A set of four triangular foam pads for the Intelli-C X-ray system to be used together with the P
• 05713464000374: A set of leg supports for the Intelli-C X-ray system for gynecological and urological examinati
• 05713464000565: End-of table radiation shield for the Intelli-C X-ray system. A lead curtain for protection agai
• 05713464000411: Radiation Shield with Top shield for the Intelli-C X-ray system. A lead curtain for protection a
• 05713464000756: A pair of Hand Grips for the Intelli-C X-ray system to be fixed freely along both sides of the t