SOLICITATION NOTICE
65 -- RADIOFREQUENCY THERAPY SYSTEM
- Notice Date
- 2/16/2012
- Notice Type
- Presolicitation
- Contracting Office
- N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
- ZIP Code
- 00000
- Solicitation Number
- N62645RCES064
- Response Due
- 3/2/2012
- Archive Date
- 4/30/2012
- Point of Contact
- BRIAN MILLER 301/ 619-1086
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 6.302-1). The proposed source is NeoMedix, 15042 Parkway Loop, Suite A, Tustin, CA 92780. The Ophthalmology Department at Naval Medical Center San Diego has a requirement for an ophthalmic tissue ablation radiofrequency therapy system. The system shall be suitable for use in electrosurgical trabeculotomy glaucoma treatment procedures. The system shall be capable of trabecular tissue ablation inside Schlemm ™s Canal by means of high-frequency (at least 500 kHz), electrical pulse. The unit shall provide a means of aspiration and irrigation of the surgical site at the time of electrosurgery, to prevent damage to surrounding tissue. The power requirement is 120V, 60 Hz, single phase. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The system shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. This acquisition is being conducted under simplified acquisition procedures FAR 13. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 334510 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to Brian Miller at brian.miller4@med.navy.mil. In addition, challenges can be faxed to 301-619-1132 Attn: Brian Miller. Email challenges are preferred. Closing date for challenges is no later than 10:00 AM. ET on 2 March 2012. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645RCES064/listing.html)
- Record
- SN02677863-W 20120218/120216235659-d394854ec4e57be0745b28c1da516529 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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