LASER LEVELING DEVICE

The contract seeks the procurement of two units of a Laser Leveling Device, specifically designed for use with the Codman CSF External Drainage System, incorporating a reusable bubble level and a Class 2 laser lamp. The item is classified under NSN 6515-01-612-7325 and is subject to FDA Regulation 878.4200 as a Class I medical device, requiring compliance with registration, listing, labeling, and good manufacturing practices even though a 510(k) submission is not mandated. Technical and quality requirements are governed by the DLA Master List of Technical and Quality Requirements, identified by 'R' or 'I' numbers, and packaging and marking must adhere to Medical Marking Standard No. 1, which supersedes MIL-STD-129. Each unit must be sealed in a protective container and packed in commercial shipping containers following MIL-STD-2073-1E packaging codes, including palletization per RP001 DLA requirements. Delivery is required within five days of order receipt at FM9133, Building 1534, 601 Davy Crockett Road, San Antonio, TX 78226, with FOB Destination terms. Inspection and acceptance occur at the destination, with FAR 52.246-2 applying. The solicitation, issued under SPE2DS-26-T-325U on August 9, 2026, with a response deadline of August 17, 2026, is processed through the DIBBS portal and incorporates the DLA Master Solicitation for Automated Simplified Acquisitions, Revision 105, along with numerous FAR and DFARS clauses covering cybersecurity, contractor reporting, export controls, hazardous materials, labor equity, subcontracting, and payment procedures. Payment is to be submitted electronically via Wide Area Workflow (WAWF), requiring contractor registration in the System for Award Management (SAM). The acquisition is not a small business set-aside but may utilize the HUBZone price evaluation preference. All offerors must represent their small business status, attest to compliance with telecommunications prohibitions, and validate all representations in SAM. The contract also mandates adherence to the Hazard Communication Standard for any hazardous materials delivered, with required labeling and Material Safety Data Sheets submitted prior to award.