OCCLUDER, EYE

The contract specifies the procurement of a single unit of an Eye Occluder, model PLAS250MM LG PLAIN HNDLE SINGLE-ENDED 70MM RAD CUP, with NSN 6540010775405 and part numbers 12113 and W0-204 from GULDEN OPHTHALMICS INC. and WESTERN OPHTHALMICS CORP. The item is classified as a Class II medical device regulated by the FDA, requiring compliance with 510(k) and additional marketing requirements including registration, labeling, and GMP standards. Delivery is due within 20 days FOB destination, with zero tolerance for quantity variance, and inspection and acceptance occur at the delivery point. Packaging must conform to Medical Marking Standard No. 1, superseding MIL-STD-129, and must ensure protection from damage during transit, with exterior shipping containers selected to enable safe and cost-effective delivery via common carrier. All packaging and labeling must follow ASTM D3951 unless superseded by DLA Master List Technical and Quality Requirements, and palletization must adhere to DLA Packaging Requirements. Shipment must be made by the fastest traceable means, excluding parcel post, to the vessel shipment address for USS RONALD REAGAN CVN 76. The contract references specific DLA procedural notes and requires the bidder to provide full manufacturer and product details to the contracting official for FDA referral prior to award.