Stratis 0.5mL Needle-Free Injection System - marketing clearance for the following Indications for use: "The PharmaJet Stratis® Needle-Free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, precise fluid stream, which penetrates the skin and delivers the medicine or vaccine to the body.

The PharmaJet Needle-Free Injector is safe, easy, cost-effective and comfortable. Needle-free injection technology significantly reduces patient fear and anx...

Tropis® marketing clearance specifies the following Indications for Use: "The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis.

NEW DESIGN
Convenient one-hand Syringe attachment and ejection
Smooth, easy trigger force and ergonomic design
Minimal dead space in the Syringe; reduced vaccine waste, Minimal Training Required, FDA cleared, CE Mark, WHO Pre-Qualified

Yes. The PharmaJet Stratis Needle-free Injector has been cleared by the FDA and other recognized international regulatory agencies. The PharmaJet Tropis device has authorization to apply the CE Mark. An FDA Master File was established in August of 2017 as a precursor to 510(k) and Tropis received WHO Pre-Qualification (PQS) in June of 2018.