Talk to the doctor about the risks and benefits of azathioprine, especially when used in children and young adults. OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional.
Each component, sub-system or accessory that is considered a medical device and is commercially available needs a separate UDI unless the components are part of a convenience, medical procedure, IVD kit or configurable medical device system that is marked with its own UDI. Kits should have their own UDI.
Medical devices sold over-the-counter generally are not approved by the FDA. This is because most over-the-counter medical devices are deemed âlow-risk,â or things that probably wonât cause life-threatening harm to a patient if used incorrectly.he FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturerâs clinical trials and other research. Based on this analysis, the agency decides whether or not to approve a drug or medical device for a particular use.