This website provides Instructions for Use (IFU) documents for products offered by Novastep. These prescription-use products are intended for use by healthcare professionals only. The IFU documents on this site are valid only on the date printed. Responsibility resides with the healthcare professional to print the IFU document on the day the product is intended to be used to ensure the most current IFU is referenced.
To view and print Instructions for Use, use the menu below to select the product. If you require additional assistance, please Contact Us.
The FDA has required that all medical device manufacturers label their products with both production identification and device identification. This requirement is called Unique Device Identification, often abbreviated as UDI. Novastep Inc had created Inventory Control Sheets to meet the UDI Point of Use requirement for non-sterile implants, which contain the product’s item number, item description and GTIN information. Inventory Control Sheets also provide entry fields to write-in the quantity and lot number of any non-sterile implant that was used. To download Inventory Control Sheets, use the menu below to select the product. If you require additional assistance, please Contact Us.
The FDA has also created Global Unique Device Identification Database (GUDID) where medical device manufacturers can upload their products’ data which is accessible to the public. To view a Novastep Products on GUDID, Click Here.