We’re thrilled to announce that our Sterile Container Systems have received 510(K233578) clearance from the FDA.
This clearance validates its safety and effectiveness using low temp VPro Steris and Sterrad sterilization modalities allowing us to bring it to market for those with end users/clients benefiting from this expansion of our quality product line’s Indications for Use.
What does this mean for our valued client base?
- Quality Assurance: The FDA rigorously evaluated our device, ensuring it meets the highest standards.
- Equivalence: Our device is equivalent to existing devices in its category, making it a reliable choice for healthcare professionals.
- An Expansion to our existing previously cleared Sterile Container Systems Indications for Use: A selection of our sterile container systems can now be offered with the additional feature of useability in numerous facilities diverse autoclave options.
The perforated bottom selection of our Containers are ideal for standardization as they are now validated for all current sterilization methods.