FlexTrak OR Ingenia 1.5T

Basic Information

• Brand Name: FlexTrak OR Ingenia 1.5T
• Primary DI: 00884838082625
• Version / Model: 989603051341
• Company Name: Philips Oy
• Labeler DUNS: 539852079
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2023-01-23
• Public Version Status: Update
• Public Device Record Key: a4704c24-ce46-4427-9dc8-540bda328d13
• Distribution End Date: 2022-10-01

Device Description

The Flextrak OR is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46148	Patient transfer system, manual	A wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance (i.e., without changing horizontal body position, lifting, rolling, or dragging). The device typically includes a patient-transfer mechanism (e.g., mechanical, hydraulic) easy to operate by an attendant with minimal physical effort. It is used in hospitals and other healthcare facilities to reduce injuries to both patients and staff while transferring non-ambulatory, comatose, or neurologically-injured patients between beds, tables, and/or stretchers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838082625	GS1

Customer Contacts

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