ORT 400 (Trumpf TruSystem 7500 MR) table

Basic Information

• Brand Name: ORT 400 (Trumpf TruSystem 7500 MR) table
• Primary DI: 00857534006516
• Version / Model: ORT 400 (Trumpf TruSystem 7500 MR) table
• Company Name: DEERFIELD IMAGING, INC.
• Labeler DUNS: 079990922
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: bd62bb60-e8c9-48bb-8aa4-d241c7dc7b28

Device Description

ORT 400 (Trumpf TruSystem 7500 MR) table Assembly, 119493-000

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
KXJ	Table, Radiologic	Radiology	892.1980	2
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40655	Basic diagnostic x-ray system table, powered	A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.	No	Active
40676	MRI system table, powered	A powered/programmable table designed with electronic and/or software controls to position and support a patient during magnetic resonance imaging (MRI) examinations. It is dedicated for use as part of an MRI system, as an integral component of the MRI system gantry, and made with ferromagnetically inactive materials to render it compatible with MRI environments. It may have a detachable table top, equipment supports, physiological monitors, mattresses, alarms and a patient positioning system (PPS).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857534006516	GS1