SPECIAL NOTICE
65 -- Notice of Intent to Sole Source - NOI
- Notice Date
- 7/13/2016
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6809616RC04005
- Archive Date
- 9/30/2016
- Point of Contact
- Yun P. Hong, Phone: 3016198895
- E-Mail Address
-
yun.p.hong.civ@mail.mil
(yun.p.hong.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR Part 13.501(a)). The proposed source is KLS-Martin LP, 11201 St Johns Industrial Pkwys, Jacksonville, FL 32247-7676. Naval Hospital (NH) Guam has a requirement for a set of Oral and Maxillofacial Surgical Instruments. The surgical instruments shall be interchangeable and compatible with the KLS Martin surgical instruments at NH Guam. The surgical instruments shall be capable of performing the following surgeries: Maxillomandibular Advancement (MMA), Surgery-Assisted Rapid Palatal Expansion (SARPE), LE FORT Osteotomy, Bilateral Sagittal Split Osteotomy (BSSO), Trauma surgeries and Orbital Floor fractures repairs. The surgical instruments shall be capable of performing Ear Nose and Throat (ENT) and Oral and Maxillofacial Surgery (OMFS) trauma surgeries. The surgical instruments shall be capable of performing Level 1 Fixations for facial trauma and orthognathic reconstruction. The surgical instruments shall be capable of imitating the following traumas for Level 1 Fixations: Midfacial trauma, Frontal and maxillary sinus, Naso- and intra-orbital region, Fixation of bone grafts, Ortho-anchorage, LeFort trauma, Mandibular fractures, Primary and secondary reconstruction of mandibular defects, Fractures in cranial high-load regions, Orthognathic, Zygoma and Orbital fractures, Bone Grafts, Fractured atrophic mandibles, Unstable oblique, angle and defect fractures, Mandibular fractures in non-compliant patients, and Mandibular reconstruction in combination with interpositional non-vascularized bone grafts. The instruments shall be capable of imitating facial, airway, and bite correction (FAB) for varying degrees of facial and airway correction. The Instruments 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. 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. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. 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 or to proceed with a sole source purchase order. Capability statements are due by 10:00 AM Local Time, 29 July 2016. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: yun.p.hong.civ@mail.mil, reference number N6809616RC04005. Phone calls will not be accepted. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6809616RC04005/listing.html)
- Place of Performance
- Address: PSC 490 BOX 7718, FPO AP, Guam, 96538, United States
- Zip Code: 96538
- Zip Code: 96538
- Record
- SN04180768-W 20160715/160713234544-bfedf34d19cae4edfd2c61a8f1b875a6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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