PAD, OPERATING TABLE

The contract is for a PAD operating table set comprising three sections: head section P/N 10104, torso section P/N 10105, and hip and foot section P/N 10101, all designated under P/N 10108 and supplied by MIZUHO ORTHOPEDIC SYSTEMS, INC. The item is regulated by the FDA as a Class I medical device under regulation 878.4950, requiring compliance with registration, listing, labeling, and GMP standards despite no 510(k) submission being mandated. It must be marked in accordance with the latest Medical Marking Standard No. 1 and packaged per MIL-STD-2073-1E and MIL-STD-129, with packaging details aligned to DLA’s packaging requirements. The unit of issue is SE, quantity is one, and delivery is FOB destination within 20 days of award, with no tolerance for variance. Inspection and acceptance occur at the destination, and shipping must be via traceable means excluding parcel post. The delivery and marking address is W501ZF, 209 Balsam LN, White River Junction, VT 05001-0000, with special marking code ZZ-ZZ indicating additional requirements. The solicitation number is SPE2DH-26-T-3280, issued under NAICS code 339113 by the Department of Defense’s Medical Supply Chain FSH, with Tina Vu listed as the primary point of contact. Technical and quality requirements referenced by R or I numbers are governed by the DLA Master List, and covered defense information provisions apply. The contract is for a government-only procurement with a required delivery date of April 24, 2026, and the response deadline was April 29, 2026.