We have over 20 years experience in creating custom solutions.
When you work with InstruSafe®, you leverage our regulatory expertise, collaborate with our engineering and design teams who have end user experience, and watch it all come to life with our vast manufacturing capabilities. OEM trays can be designed for use with various sterilization cycles, with wrap or rigid containers.
We are the OEM tray manufacturer with FDA 510(k) clearances needed to get your project started or pair with your existing instrument validations.
From a single instrument to a full set, delicate or robust; we will design and manufacture a tray to provide optimal protection while complying with FDA regulations and AAMI standards.
Every project is unique. Working together and understanding our customer’s goals is vital to meeting expectations.
Our team has years of experience in sterile processing and the operating room. This helps provide a unique end user perspective when developing your project.
Our facilities are ISO 13485 : 2012 Certified, we have CE certifications and an extensive portfolio of FDA 510(k) Clearances for various sterilization cycles.
Our company culture enables us to establish goals to meet or exceed project timelines and turnaround quick manufacturing lead times.
Designed to ensure optimal sterilization, InstruSafe OEM trays are cleared for various sterilization cycles in both wrap + rigid containers. Each tray meets our criteria to be covered by all our cleared cycles. This gives the customer a complete solution ready for market.
For more information about current sterilization validations go to our resources page here.
See a list of our OEM capabilities here.