SOLICITATION NOTICE
65 -- Craniofacial System
- Notice Date
- 1/23/2009
- Notice Type
- Modification/Amendment
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 1681 Nelson St, FT Detrick, Maryland, 21702-9203
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264509RCES069
- Response Due
- 1/28/2009 12:00:00 PM
- Archive Date
- 2/12/2009
- Point of Contact
- Erin Cotter,, Phone: 301-619-1086, Burzie C Baker III,, Phone: 301-619-0707
- E-Mail Address
-
erin.cotter@med.navy.mil, burzie.baker@med.navy.mil
- Small Business Set-Aside
- Partial Small Business
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with OsteoMed, 3885 Arapaho Rd, Addison Tx, 75001-4314, as the only responsible source that can provide a craniomaxillofacial system that would be compatible with the Anspach Middle Ear drill units that are part of the installed base at NMC San Diego. The requirement is for a Craniomaxillofacial System for NMC San Diego. The system shall include 1.2 mm, 1.6 mm, 2.00mm, and 2.4mm modules. Each module shall include screws, various plates, and emergency screws. The system shall include instrumentation compatible with the various plates and screws and be compatible with the Anspach Middle Ear drill system. Regulatory Requirements: The system and all of the components, 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. DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND SYNOPSIS AND SOLICITATION The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with OsteoMed, 3885 Arapaho Rd, Addison Tx, 75001-4314, as the only responsible source that can provide a craniomaxillofacial system that would be compatible with the Anspach Middle Ear drill systems, without special attachments, that are part of the installed base at NMC San Diego. Regulatory Requirements: The system and all of the components, 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. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement shall be classified under North America Industry Classification System (NAICS) 339112. 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, including cost, 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. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to erin.cotter@med.navy.mil or faxed to Erin Cotter @ 301.619.2925. No phone calls accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=58066e33c3c4a037f5ac65da0e8b35d4&tab=core&_cview=1)
- Place of Performance
- Address: NAVAL MEDICAL CENTER SAN DIEGO, San Diego, California, 92134, United States
- Zip Code: 92134
- Zip Code: 92134
- Record
- SN01737291-W 20090125/090123223818-58066e33c3c4a037f5ac65da0e8b35d4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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