FDA.reportPublic FDA data

Intelli-C Accessory

Primary DI
05713464000428
Brand
Intelli-C Accessory
Company
Nrt - Nordisk Røntgen Teknik A/S
Model
03285000
Device description
Side Bar for the Intelli-C X-ray system. A long side bar to be fixed in any position along the table top designed to support the patient while rolling over for various examinations.
Published
2019-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
OWBInterventional Fluoroscopic X-Ray System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
OWBInterventional Fluoroscopic X-Ray SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173631000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173631000Intelli-CNrt X-Ray A/S2018-07-11OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713464000428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713464000428057134640004285713464000428

GMDN Terms#

Term, Definition table
TermDefinition
BedrailA rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an "up" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4586283500nrt@nrtxray.com

Regulatory Flags#

DUNS number
307332705
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713464000640Adora Accessory042822002025-09-16
05713464000657Adora Accessory042834002025-09-16
05713464000664Adora Accessory042863902025-09-16
05713464000671Adora Accessory042865002025-09-16
05713464000688Adora Accessory042866002025-09-16
05713464000695Adora Accessory042895002025-09-16
05713464000701Adora Accessory042822402025-09-16
05713464000862Adora DRFi045500102025-09-16
05713464000329Intelli-C Accessory029199002019-01-21
05713464000435Intelli-C Accessory032856002019-05-01
05713464000442Intelli-C Accessory213200182019-05-01
05713464000459Intelli-C Accessory213300182019-05-01
05713464000756Intelli-C Accessory032849002022-05-31
05713464000343Intelli-C Accessory032845002019-01-21
05713464000732Intelli-C Accessory032820002022-04-11
05713464000749Intelli-C Accessory032830002022-04-11
05713464000336Intelli-C Accessory032820002019-01-21
05713464000381Intelli-C Accessory032830002019-02-19
05713464000411Intelli-C Accessory032840502021-04-16
05713464000565Intelli-C Accessory032842002021-04-16

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