Electrosurgical unit (ESU)

The FDA's Center for Devices and Radiological Health seeks to purchase one commercial Electrosurgical Unit (ESU) with accessories, with quotations due September 2 and questions due August 30. No set-aside applies. This is subject to Buy American Act compliance requiring domestic end products.

Place of performance is Silver Spring, Maryland. The ESU must feature a touchscreen user interface, real-time tissue impedance monitoring at a minimum rate of 434,000 times per second, output frequency between 400 kHz and 500 kHz, and support seven specified operating modes: monopolar CUT (Pure and Blend), monopolar COAG (Fulgurate, Spray, and Soft), bipolar coagulation, and vessel sealing. The contractor must provide all accessories for complete operation (monopolar electrodes with holster and switch, patient return electrodes, bipolar forceps with cord and footswitch, and vessel sealers with switches), user and technical documentation, and a minimum 12-month manufacturer's warranty covering parts, labor, and service. Delivery is due within 30 calendar days after contract award, with installation required at the destination. The equipment shall be new, unused, and fully operational upon completion of installation.

NAICS 339112 applies; small business size standard is 1,000 employees. Award will be made on a Lowest Price Technically Acceptable (LPTA) basis to the responsible quoter submitting the lowest-priced quotation meeting all salient characteristics and mandatory minimum requirements. Offerors must submit technical quotation with manufacturer information, make/model, product literature, cross-references to technical requirements, price quotation, warranty terms, UEI and SAM.gov registration, and lead time. The Contracting Officer is Maria Finan (240-402-5712, Maria.Finan@fda.hhs.gov) and Contract Specialist is Reagan Davis (301-792-0910, Reagan.Davis@fda.hhs.gov). All invoices must be submitted electronically through the Department of Treasury's Invoice Processing Platform.