iFIX

Basic Information

• Brand Name: iFIX
• Primary DI: 09010279001050
• Version / Model: iFIX Arm Rest Tray
• Catalog Number: 55807
• Company Name: iSYS Medizintechnik GmbH
• Labeler DUNS: 300207996
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-30
• Public Version: 1
• Public Version Date: 2024-08-07
• Public Version Status: New
• Public Device Record Key: 83717fd3-ce73-4024-9a4a-014523216fce

Device Description

iFIX Tray is a extremity support product, a part of iFIX Arm Rest. It is a long top surface capable of fitting the PearlFit Cushion 50x20x4 (P/N 1124-A) for patient comfort.

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 Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
FMQ	Restraint, Protective	General Hospital	880.6760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63966	Medical table restraint anchor	A device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09010279001050	GS1