Intelli-C Accessory

GUDID 05713464000374

A set of leg supports for the Intelli-C X-ray system for gynecological and urological examinations. The leg supports can be placed freely along the table top.

Nrt - Nordisk Røntgen Teknik A/S

Radiological arm/leg positioner
Primary Device ID05713464000374
NIH Device Record Key595a3a8a-461b-4c08-9afd-49983de05fc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntelli-C Accessory
Version Model Number03282600
Company DUNS307332705
Company NameNrt - Nordisk Røntgen Teknik A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com
Phone+4586283500
Emailnrt@nrtxray.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105713464000374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAASystem, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-28
Device Publish Date2020-10-20

On-Brand Devices [Intelli-C Accessory]

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