SOLICITATION NOTICE
65 -- Surgical Sets
- Notice Date
- 9/2/2005
- Notice Type
- Solicitation Notice
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, MD, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N62645-05-T-0108
- Response Due
- 9/16/2005
- Archive Date
- 10/1/2005
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. The Request for Quote (RFQ) number is N62645-05-T-0108. Provisions and clauses in effect through Federal Acquisition Circular 2005-05 are incorporated. NAICS 423450. The Naval Medical Logistics Command intends to negotiate (IAW FAR 6.302-1) with Synthes, 1690 Russell Road, Paoli, PA, 19301 as the only source that can provide Surgical Sets. 1) SALIENT CHARACTERISTICS: A) The Naval Medical Logistics Command has a requirement for Surgical Sets that are capable of being used with the current Synthes Surgical Sets. B) These Surgical Sets shall be capable of being used in orthopedic surgery to make surgical repairs of wartime injuries to the body. C) The Surgical Sets will only work with the current Surgical Sets. D) The Surgical Sets consist of the following. 1) 24 components of the distal radius set, 2) 22 components of the 4.0 cannulated screw set, 3) 106 components of the modular hand set, 4) 63 components of the orthopedic surgical set, 5) 36 components of the DHS/DCS surgical set, 6) 41 components of the 3.0 cannulated screw set, 7) 30 components of the 7.3 cannulated screw set, 8) 26 components of the titanium mini-fragmentation set, 9) 15 components of the 3.5 cannulated partially threaded screw set, 10) 113 components of the small fragmentation locking screw set, 11) 53 components of the large fragmentation set. D) The JRCAB/DMSB standardized the make and model of implants and the associated instrument sets for field surgery in order to insure compatibility of instruments with the implants throughout the spectrum of field medicine. 2) REGULATORY REQUIREMENTS: The Surgical Sets and all of it?s components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver a medical product 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. 3) SYSTEM REQUIREMENTS: A) The Surgical Sets shall be capable of being used in the current Synthes Surgical Sets. B) The Surgical Sets consist of various screws and bone plates, that when sterilized, are capable of being used during orthopedic surgery to repair injuries to the body. Specific information about the Surgical Sets can be obtained from the point of contact listed below. C) The Surgical Sets are replacement parts of items that have been used during surgery. D) Due to manufacturer proprietary interchangeable parts, the Surgical Sets cannot be substituted with any other manufacturer?s Surgical Sets. E) Therefore, only Synthes Surgical Sets can be used with the Synthes Surgical Sets. PROPOSAL REQUIREMENTS: (1) A document addressing compliance for each numbered paragraph of the SALIENT CHARACTERISTICS. This document shall be in sufficient detail to show compliance with all items specified under the numbered paragraphs. In the event of a "no concur", an explanation must be provided to support. (2) Any brochures, technical or product literature to support the items offered. (3) For past performance, provide dates of contracts or purchase orders, both Government and commercial, for the systems sold commercially (minimum of 3 different sales) within the past 3 year period as follows: Name, address, POC and telephone number of the organization; contract or purchase order number and dollar value; date of contract or purchase order. Contract award will be based on 1) determination of technical acceptability of items offered to meet salient characteristics, regulatory requirements and systems requirements, 2) interoperability with Synthes Surgical Sets, 3) past performance, and 4) price. Companies must be registered in CCR; provide DUNS number; Cage Code and TIN. Companies must also comply with DFARS 252.232-7003, ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (JAN 2004). PROVISIONS at FAR 52.212-1, Instructions to Offerors---Commercial Items, apply to this acquisition with the exception of (d), (h), and (i) of the clause, which are RESERVED. Offeror shall include a completed copy of provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, with their offer. Offeror shall include a completed copy of provision at DFARS 252.212-7000, Offeror Representations and Certification-Commercial Items. Addenda to this provision include FAR 52.247-34, F.o.b. Destination; DFARS 252.225-7000, Buy American Act-Balance of Payments Program Certificate; 252.225-7006, Buy American Act-Trade Agreements-Balance of Payments Program Certificate; and 252.225-7035, Buy American Act--North American Free Trade Agreement Implementation Act--Balance of Payments Program Certificate. FAR 52.212-4, Contract Terms and Conditions---Commercial Items, applies to this acquisition. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. In compliance with said clause, the following FAR clauses apply: 52.203-6, Restrictions on Subcontractor Sales to the Government, with Alternate I; 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36, Affirmative Action for Handicapped Workers; 52.222-37, Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era. DFARS 252.212-7001, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders---Commercial Items, applies to this acquisition. In compliance with said clause, following additional DFARS clauses apply: 252.205-7000, Provision of Information to Cooperative Agreement Holders; 252.219-7005, Incentive for Subcontracting with Small Business, Small disadvantaged Businesses, Historically Black Colleges and Universities and Minority Institutions, Alternate I; 252.225-7001, Buy American Act and Balance of Payment Program; 252.225-7007, Trade Agreements; 252.225-7012, Preference for Certain Domestic Commodities; 252.225-7036, North American Free Trade Agreement Implementation Act; 252.247-7024, Notification of Transportation of Supplies by Sea. See numbered note number 22. Proposals shall be submitted by email only to Russell Grabill at rjgrabill@nmlc.med.navy.mil. Proposals are due by 1 p.m. by 16 September 2005. Any questions must be addressed only to Russell Grabill by email, by 1 p.m. by 14 September 2005. No phone calls accepted.
- Place of Performance
- Address: NAVAL MEDICAL LOGISTICS COMMAND, 1681 NELSON STREET, FORT DETRICK MD
- Zip Code: 21702-9203
- Country: USA
- Zip Code: 21702-9203
- Record
- SN00886183-W 20050904/050902212428 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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