ONE TRAY®’s original clearance in 2006 (IFU K052567*) included sterilization at 270°F (132°C), Exposure Time 4 minutes, Cycle Dry Time Not Required and validated to maintain the sterility of the contents for up to a 48 hour storage period.

ONE TRAY®s NEW additional clearance in 2025 (IFU K250029**) maintains the same validated sterilization parameters – 270°F (132°C), Exposure Time 4 minutes, but with a 365 day event related shelf life/storage period with a 15-minute minimum dry time.

When introduced in 2006, ONE TRAY® represented a new approach to sealed sterilization container technology. Now, according to Barbara Ann Harmer MHA, BSN, RN, Vice President of Clinical Services at IST, the expanded storage window provides facilities with even more operational flexibility.