ROTOMETRICS ROTOREPEL™ Rx NON STICK COMPLIANT WITH US FOOD AND DRUG ADMINISTRATION FOOD CONTACT REGULATIONS AND RECEIVES MASTER FILE (MAF)
The formulation for RotoRepel™ Rx nonstick rotary die treatment has undergone a US Food and Drug Administration regulatory compliance review, migration testing, and toxicological safety assessment. RotoRepel™ Rx is safe for intended use in conversion of parts, devices and labels. Additionally, RotoRepel™ Rx is compliant with US FDA food contact regulations. RotoRepel™ Rx is filed with the US Food and Drug Administration under Master File for Devices (MAF) #2975.
“We are extremely excited for new RotoRepel™ Rx to be on file with the US FDA.” said Keith Laakko, Vice President of Marketing for RotoMetrics. “RotoRepel™ Rx opens the door for customers to use our innovative no-stick and enhanced die performance treatment in new applications. Customers have access to our filing as a portion of a 510(k) submission to the FDA. This is great news for customers converting parts, devices and labels in medical and other related industries. Additionally, our formulation is compliant with food contact regulations so it safe for intended use in food contact applications for packaging, parts, and labeling.”
New RotoRepel™ Rx offers exclusive nonstick and enhanced press performance benefits, including:
- Presses run faster
- Reduction of adhesive buildup – on all adhesive types
- Significant improvement in press uptime
- Less die damage because of less handling
- Dies are easier to clean and return to inventory ready to run
- Fewer missing labels and a reduction of blocking during rewind
- Significant reduction in static at the die station
To learn more go to http://www.rotometrics.com/our-products/flexible-dies/rotorepel-no-stick-treatment/