BRACE, ANKLE

The contract pertains to the procurement of ankle braces, identified by NSN 6515-01-699-6619 and manufacturer part number AY-81-103BK-SG, with a quantity of five units required. Delivery is to be made FOB destination within five days of contract award, with no variance allowed in quantity. The items must comply with DLA’s packaging and marking standards, specifically Medical Marking Standard No. 1, which supersedes MIL-STD-129, and must be packaged in sealed unit containers suitable for protection during transit, with exterior shipping containers meeting commercial standards for safe and economical delivery. The product is classified as a FDA-regulated Class I medical device, requiring compliance with registration, listing, labeling, and GMP requirements, even if a 510(k) is not mandated. All packaging and labeling must adhere to DLA’s procurement guidelines, including palletization per RP001, and the items must be shipped to the delivery point at Rose Barracks, Vilseck, Germany. The solicitation number is SPE2DS-26-T-252K, issued under the Department of Defense, with a required delivery date of July 22, 2026, and the contract is subject to oversight for covered defense information and other regulatory compliance as outlined in applicable DLA master requirements.