Promisemed Hangzhou Meditech Co., Ltd. SPN-30-8 Assure® ID Safety Pen Needle

The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length.The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication.The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle byproviding a shield that covers and locks the needle after use. As the user proceeds with inserting theneedle into the skin the shield will retract. After the injection is completed and needle is removedfrom the skin, the shield will automatically extend to cover the needle and lock in place. Once theSafety Type Insulin Pen Needle is in the locked mode, it can no longer be used.The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.