BRACE, WRIST AND FOREARM

The contract specifies the procurement of a medium-sized D-ring thumb and wrist orthosis designed for the right hand, with a circumference range of 7 3/4 to 8 3/8 inches (20 to 21 cm), issued in units of each. The item is regulated by the FDA as a Class I medical device, requiring compliance with registration, listing, labeling, and Good Manufacturing Practices, even if a 510(k) submission is not mandatory. The product, manufactured by North Coast Medical, Inc. under part number NC91265, must adhere to strict medical packaging and marking standards, including Medical Marking Standard No. 1, which supersedes MIL-STD-129. Each unit must be sealed in a protected container and packed in commercial shipping containers suitable for safe, cost-effective delivery. Packaging and palletization must follow DLA’s RP001 requirements and MIL-STD-2073-1E guidelines. The delivery is FOB destination, with a required delivery date of July 23, 2026, and a 84-day lead time. Two units are ordered at a unit price of $2.00, totaling $4.00, with zero variance allowed. The destination for delivery is APO AE 09227-0000, with additional logistical instructions for transportation and freight addressed to the U.S. Medical Material Center in Kaiserslautern, Germany. Technical and quality requirements referenced in the DLA Master List apply, and the solicitation was issued under contract number SPE2DS-26-T-265K.