Class I - Dangerous
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
Jewel Precision Sheet Metal & Machining Co
Class I - Dangerous
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.