FLEXcon® MedFLEX™ Product Line Meets All Performance Criteria of the Proposed Rule for the Unique Identification of FDA Class II and III Medical Devices .
FLEXcon, an innovator in adhesive coating and laminating, today announced the launch of FLEXcon® MedFLEX™, a line of label substrates that meets all performance criteria required by the Food and Drug Administration’s (FDA) proposed unique device identifier (UDI) rule. The legislation will require Class II and III medical devices distributed in the U.S. to carry a unique numeric or alphanumeric code with an identifier specific to each device or model as well as an identifier with current production information. The FLEXcon MedFLEX line is UL-certified in accordance with UL/IEC 60601-1 3rd edition marketing durability rub tests and all products are available for immediate UL adoption.
"The FDA's pending legislation will prompt more than 21,000 medical device manufacturers globally to undergo an analysis of their current practices to meet all requirements. This will include investigations into alternative labeling materials and requests for procurement to update material buys,” said Ken Koldan, new business development manager, FLEXcon. “The FLEXcon MedFLEX product line opens up new market opportunities for converters and printers and gives them a head start in delivering immediately adoptable, UL-recognized label materials designed specifically for the medical device industry.”
In addition to the usage of materials that comply with UL/IEC 60601-1 3rd edition marking durability rub tests, and potentially UL-recognized materials, the FDA UDI rule will also require specific information and barcodes on all product labels. Manufacturers will also need to maintain the data gathered for track and trace purposes. FLEXcon MedFLEX products not only meet these requirements, they utilize FLEXcon’s high-performance acrylic adhesives and their best thermal transfer printable topcoats. Three of the products are UL-recognized with inks and ribbons and all products are immediately adoptable into converters’ UL files.
• FLEXcon MedFLEX PM2C15K, PM2W15K and MM2SM15K, 2 mil gloss topcoated polyesters in clear, white and silver matte
• FLEXcon MedFLEX PM2W22K, a 2 mil white gloss topcoated polyester
• FLEXcon MedFLEX PM2W36K and PM2W36G, 2 mil white matte topcoated polyesters
• FLEXcon MedFLEX OM1C05P and OM1CM05P, 1 mil clear and clear matte overlaminating polyesters
For specific product information, visit www.FLEXcon.com/MedFLEX.
FLEXcon prides itself on delivering much more than innovative solutions. The company also serves as a strategic collaborator to printers and converters, helping them navigate any new legislative or industry standards to ensure they have every opportunity to stay ahead of market demands and grow their businesses. FLEXcon’s standing as a recognized leader in connection with UL positions the company as a valuable resource for better understanding of new regulations and compliance issues.
To stay updated on the latest developments on the FDA UDI ruling, join Ken Koldan and other industry leaders in the Unique Device Identification LinkedIn group. You can also read the actual proposed rule by visiting www.fda.gov and keep up on the status at www.regulations.gov.