Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 03, 2024 SAM #8193
SPECIAL NOTICE

65 -- Notice of Intent to Sole Source ReActiv8 Implantable Pulse Generators for Naval Medical Center San Diego

Notice Date

5/1/2024 11:20:04 AM
 

Notice Type

Special Notice
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

DEFENSE HEALTH AGENCY FALLS CHURCH VA 22042 USA
 

ZIP Code

22042
 

Solicitation Number

HT941024N0063
 

Response Due

5/8/2024 1:00:00 PM
 

Archive Date

05/23/2024
 

Point of Contact

Jennifer Collins, CHA-ON Gordon, Phone: 9103647160
 

E-Mail Address

jennifer.e.collins23.civ@health.mil, cha-on.p.gordon2.civ@health.mil
(jennifer.e.collins23.civ@health.mil, cha-on.p.gordon2.civ@health.mil)
 

Description

Notice of Intent to Sole Source RE: HT941024N0063 THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE SUPPLY CONTRACT AND IS NOT AREQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Western Healthcare Operations Contracting Division (WHOCD), intends to award a firm fixed price supply purchase for Reactiv8 Implantable Pulse Generators for use in surgery at Naval Medical Center San Diego (NMCSD), in accordance with the Federal Acquisition Regulation (FAR) 13.501(a) Sole Source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government�s needs, to: �MML US, Inc. �2159 India Street �STE 200 �San Diego, CA 92101-1766 The North American Industry Classification System (NAICS) code for this requirement is 339112 � Surgical and Medical Instrument Manufacturing; the business size standard is 1000 (in employees). The Product Service Code (PSC) is 6515 � Medical and Surgical Instruments, Equipment, and Supplies. The objective of this sole source award is to procure Reactiv8 pulse generators for Naval Medical Center San Diego. The required Reactiv8 implantable neurostimulation pulse generator is the only medical device of its kind in the marketplace, based on its restorative therapy, mechanism of action, and patent portfolio.� Reactiv8 is indicated for bilateral stimulation of the spine as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.� There is not a reasonable expectation that offers will be obtained from at least two (2) responsible sources offering the pulse generator implant required by NMCSD. Deliver By: 1 June 2024 MML US, Inc. is the only source that can meet the Government�s minimum requirements to provide the requested customized implant above at Naval Medical Center San Diego. This notice of intent is not a request for competitive proposals, and no solicitation document exists for this 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 provide the required customized implant for Naval Medical Center San Diego. Capability statements shall not exceed six (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. If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Jennifer Collins at Jennifer.E.Collins23.civ@health.mil. The closing date for challenges is no later than 1300 Pacific Daylight Time, Thursday, 16 May 2024. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/f72f9ee11cc24094a0e53ceb7daa0924/view)
 

Place of Performance

Address: San Diego, CA 92139, USA

Zip Code: 92139

Country: USA
 

Record

SN07048039-F 20240503/240501230036 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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