Description
The FDA CDRH is seeking quotations for one (1) brand‑new commercial Electrosurgical Unit (ESU) with a full suite of accessories, technical documentation, installation, and a one‑year manufacturer’s warranty. The ESU must feature a touchscreen interface, real‑time tissue impedance monitoring (≥434 kHz sampling), output frequency 400‑500 kHz, and support monopolar, bipolar, and vessel‑sealing modes. Delivery is required within 30 calendar days to the FDA facility in Silver Spring, MD, with acceptance contingent on successful installation and compliance with the technical specifications. The award will be made to the lowest‑priced quotation that is technically acceptable (LPTA).
• Quantity: 1 complete ESU system with all required accessories
• Mandatory new, unused equipment – no refurbished units
• Required accessories include monopolar electrode set, patient return electrode, bipolar forceps with footswitch, and vessel sealer
• Technical documentation and a minimum one‑year warranty must be provided
• Delivery & installation within 30 days of contract award, FOB Destination
• Evaluation: Pass/fail technical compliance, then lowest price among acceptable offers