InstruSafe Trays have a 510(k) clearance for each sterilization cycle listed when using wrap as a sterile barrier and as indicated when using with rigid containers.
*Click on the sterilization cycle name for a link to the FDA 510(k) premarket notification.
|*For compatible rigid container size information, see Appendix A in the back of the InstruSafe IFU.|
|Sterilization Cycle||Wrap||Aesculap Rigid Container||Genesis Rigid Container|
|Steam 4 minute||x||x||x|
|STERRAD® 100S Standard||x||x|
|STERRAD® 100NX Standard||x||x|
|STERRAD® 100NX Express||x|
|STERRAD® 100NX Flex||x||x|
|STERRAD® NX Standard||x||x|
|Steris® V-PRO® 1, V-PRO 1 Plus and V-PRO maX||x||x|
At Summit Medical, we are committed to providing as many sterilization cycle options as possible providing you the flexibility your facility needs.
We are constantly working to validate our InstruSafe products for variety of available sterilization cycles like STERRAD, STERIS V-Pro, and low- temperature cycles as well as obtain clearances for new cycles.