SOLICITATION NOTICE
65 -- Integra UNI-CP Plate and Screw Set
- Notice Date
- 3/27/2017
- Notice Type
- Presolicitation
- 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
- N0025917RCD0214
- Archive Date
- 9/30/2017
- Point of Contact
- Derek J. Bell, Phone: 3016196914
- E-Mail Address
-
derek.j.bell.civ@mail.mil
(derek.j.bell.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command (NMLC) intends to negotiate on a sole source basis (IAW FAR 13.106-1(b)(1) sole source (including brand name) acquisitions. The proposed source is Integra Lifesciences Corporation, 311 Enterprise Dr., Plainsboro, NJ, 08536-3344. The Orthopedic Department is in need of a duplicate Integra UNI-CP plate and screw set to increase the current inventory, eliminating the one of one tray. 1. Shall have a locking cap, with locking technology for fixation and load 2. Shall be Low profile 3. Screws and plates shall be compatible with the currently owned UNI-CP Integra set and instrumentation. 4. Screws shall be 3.5mm in diameter, 12mm-34mm in 2mm increments. 5. Shall be stainless steel implants. 6. Shall have 2 hole plate and 4 hole plate design in a "U", "T" and "Dog bone" shape. 7. Tray shall be identical to the currently owned Integra UNI-CP set. The Orthopedic Department is in need of Integra UNI-Clip Large Compression Implants for restock of a currently owned Integra UNI-Clip Tray. UNI-Clips shall be: 1. Diamond designed bridge. 2. Internal notches. 3. Straight Interaxis Staples leg lengths (20) 20-20mm, (25) 25-25mm. 4. Offset Interaxis staples leg (25) lengths 20-25mm, (30) 27-32mm. 5. Stainless Steel. 6. Compatible with the currently owned tray. 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. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. 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. 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 1000. 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 Derek Bell at derek.j.bell.civ@mail.mil. Closing date for challenges is no later than 3:00 PM ET on 11 Apr 17. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N0025917RCD0214/listing.html)
- Record
- SN04448723-W 20170329/170327234931-7fb2fc3d25adc0ca4a4cdfc9e76fc3ac (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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