PAD, POSITIONING, SURGICAL

This contract is for the procurement of six cases of medium single-use surgical positioning cushion inserts, manufactured by Mizuho Orthopedic Systems under part number D28505CE. These inserts are specifically designed for use with the ProneView helmet on the ProneView spinal surgery table platform and are guaranteed to be free of natural rubber latex. As an FDA-regulated Class I medical device, the item is identified as a commercial off-the-shelf product that must comply with registration, listing, and labeling requirements. The agreement specifies that all items must be delivered FOB destination to the US Naval Hospital in Okinawa, Japan, within 20 days. Packaging must meet commercial standards to protect against damage and must be marked according to Medical Marking Standard No. 1. The contract is managed by the Department of Defense Medical Supply Chain and requires strict adherence to DLA packaging and palletization requirements.