New Claims for a Safer Outcome

 Case Medical Receives New 510k Clearance

 

Case Medical is a proud recipient of a new FDA 510k for the SteriTite® container system with MediTray® products.

  • One (1) year sterile shelf life/maintenance of sterility claim
  • Reduced dry time claim for Pre-Vacuum Steam Sterilization: “Dry loads will be achieved using a minimum of 5 minutes dry time when using perforated bottom units and a minimum of 8 minutes dry time when using solid bottom units”
  • Compatibility with Table Top Pre-Vacuum Steam Sterilization: Container sizes are limited due to the small chamber of the table top sterilizer

The SteriTite® container is a universal system used to enclose other medical devices, which are to be sterilized, transported, and stored by a health care provider. SteriTite® containers were previously cleared for steam sterilization, terminal and IUSS (flash), as well as for all current low temperature modalities. The new claims indicate that the SteriTite® container may now be used for storage and transport after steam sterilization with a reduced dry time.

Case Medical supports best practices. We also understand that time is an important consideration when processing sets for the OR. In the past, Case Medical recommended a 20-30 minimal dry time for sterilized loads utilizing the company’s container system. Case Medical now claims accelerated dry times of 5 to 8 minutes utilizing its existing container system with paper filters.

Our customers have been asking us for quick turn-around of sterilized items, compatibility with tabletop autoclaves, and a claim of one year shelf life in addition to our previous claims of event related sterility maintenance. In recognition of those needs and the importance of terminal sterilization with dry loads, Case Medical is pleased to share with you our new claims.

For more information contact us at info@casemed.com

Warm Regards,

Marcia Frieze, CEO, and the Case Medical Team

Case Medical | 19 Empire BLVD., South Hackensack, NJ
201-313-1999 | www.casemed.com | info@casemed.com