BRACE, WRIST AND FOREARM

The contract specifies the procurement of a wrist and forearm brace under solicitation SPE2DS-26-T-238R, with a single unit required for delivery within five days to a designated military medical facility in San Antonio, Texas. The item is classified as a FDA-regulated Class I medical device, requiring compliance with registration, listing, labeling, and GMP standards regardless of whether a 510(k) is needed. Packaging must conform to commercial standards as defined in the procurement document, with each unit sealed in a protective container and shipped in exterior containers that ensure safe, low-cost delivery via common carrier. All materials must be marked in accordance with Medical Marking Standard No. 1, which supersedes MIL-STD-129, and packaging must align with DLA’s RP001 requirements and be palletized appropriately. The item’s NSN is 6515-01-714-0067, the purchase request is 7017446527, and delivery is FOB destination with no tolerance for quantity variance. The recipient requires shipment by the fastest traceable means—parcel post is prohibited—and the delivery must occur no later than July 14, 2026. Technical and quality requirements are governed by the DLA Master List of Technical and Quality Requirements, and the contracting official must submit an EBS referral to confirm FDA regulatory compliance before award.