SPECIAL NOTICE
65 -- SURGICAL INSTRUMENTS
- Notice Date
- 8/15/2013
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264513RCES090
- Archive Date
- 9/30/2013
- Point of Contact
- Brian D. Miller, Phone: 3016191086
- E-Mail Address
-
brian.miller4@med.navy.mil
(brian.miller4@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is SportsTek Medical Inc, 27383 Via Industria, Temecula, CA, 92590. Naval Hospital Yokosuka has a need for surgical instruments. The surgical instruments shall be indicated for use in anterior cruciate ligament (ACL) reconstruction surgery. The instruments shall include twenty four (24) cannulated reamers, eight (8) bone screwdrivers, and drill and tissue guides to aid in ACL reconstruction surgeries. The cannulated reamers shall range in diameter from 5mm to 10mm in 0.5mm increments. The requirement is for two (2) cannulated reamers of each diameter. The bone screwdriver requirement shall include two (2) each of screwdrivers capable of driving the following screws: Arthrex 10mm Bio-Tenodesis Screw, Arthrex 12mm Bio-Tenodesis Screw, Arthrex 15mm Bio-Tenodesis Screw, Arthrex 23mm Bio-Tenodesis Screw. The instruments shall also include two (2) graft preparation workstations and all associated hardware, as well as four (4) bone drills specific to ACL reconstruction surgery. The graft preparation workstations shall be capable of preparing grafts from patellar tendon and hamstring tendon tissue. The surgical instruments shall be compatible with the installed base of Arthrex surgical instrumentation and Arthrex surgical implants at Naval Hospital Yokosuka. Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems 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 equipment 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 equipment shall be installed in compliance with OSHA requirements. There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 339112 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 2:00 PM. ET on 30 August 2013. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264513RCES090/listing.html)
- Place of Performance
- Address: Naval Hospital Yokosuka, United States
- Record
- SN03151540-W 20130817/130816000658-a8ae37c392ebfd8df0a462a25fe78ee1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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