Catheter, Drainage, Intraoral/Extraoral

What Is It?

To allow continuous drainage of saliva and/or fluid irrigation of the salivary duct as well as assisting in maintaining duct patency during the healing process following removal of salivary gland stones for temporary insertion into the salivary gland, whether orally or through the cheek following endoscopic or surgical removal of salivary gland stones

What Is FDA Product Code OAJ?

Catheter, Drainage, Intraoral/Extraoral is FDA product code OAJ, Class 1, 21 CFR 878.4200.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.