BRACE, ANKLE

The contract entails the procurement of 10 ankle braces under solicitation SPE2DS-26-T-011V, with a required delivery within 84 days to the destination APO AE 09227-0000. The item is regulated by the FDA as a Class I medical device, requiring compliance with registration, listing, labeling, and GMP standards regardless of whether a 510(k) is needed. Packaging must adhere to commercial standards in accordance with Medical Marking Standard No. 1, superseding MIL-STD-129, and must ensure protection from damage during transit. All units must be sealed in suitable containers and packed in commercial shipping containers capable of secure, cost-effective delivery by common carriers. Palletization and packaging must follow DLA’s packaging requirements, and marking must strictly comply with specified medical standards. The device is supplied by CRUZE DISTRIBUTION, LLC under part number AY-81-103BK-SG and SCHOOL HEALTH CORP under part number 1035314, with an agreed unit price of $10.00 for a total value of $100.00. The contract prohibits any variance in quantity, with inspection and acceptance occurring at the delivery point. The item is subject to Covered Defense Information requirements, and all shipments must align with DLA procurement notes and transportation guidance. The solicitation response deadline is May 4, 2026, with a target original delivery date of April 24, 2026.