Solicitation Number: 36C25619Q1142 Notice Type: Intent to Sole Source Synopsis: The Michael E DeBakey VA Medical Center NCO (16) intends to negotiate on a sole source basis (IAW FAR 13.501) with KARL STORZ Endoscopy-America, Inc, 2151 E. Grand Avenue, El Segundo, CA 90245 as the only responsible source that can provide the endoscopy instruments identified below. The Michael E. DeBakey VA Medical Center )MEDVAMC) currently utilizes the Karl Storz Mini PCL Instrument Sets during Urologic cases in the Operating Room. Additional sets are required sue to an increased volume of Urologic cases. In order to maintain Medical Instrument Standardization within the MEDVAMC, the exact instrument must be obtained. The instruments are identified below. The total purchase order amount is estimated to be $18,096.04. 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. There are no set-aside restrictions for this requirement. The intended procurement will 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 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 to [email protected] no later than 3:00 PM cst on July 09, 2019. No phone calls accepted. 27830KAA Nephroscope F/MIP M 1 27001GP Instrument Port w/ Sealing System 1 27550N Instrument Port Seals 2 27001GG Large Instrument Port w/ Sealing System 1 7037595 Cone for use with Instrument Port 2 7624890-10 Rubber Tip with Hole 2 27820AB Dilator, 11/12 FR., For MIP S 1 27830AA One Step Dilator, Channel F/Guide Wires 1 27830AB One Step Dilator, w/ Distal Curved Channel 1 27830AC One Step Dilator, w/ Distal Curved Channel 1 27830BA 15/16FR Operating Sheath F/Continuous Irrigation 1 27830BB 16.5/17.5 Operating Sheath F/Continuous Irrigation 1 27830BC 21/22FR Operating Sheath F/Continuous Irrigation 1 27830BAS 15/16FR Operating Sheath F/Continuous Flow 1 27830BBS 16.5/17.5FR Operating Sheath F/Continuous Flow 1 27830BCS 21/22FR Operating Sheath F/Continuous Flow 1 27830BK Operating Sheath for Children, 16.5/17.5 FR 1 27830CF Applicator for Sealing F/Use w/ Operating Sheaths 1 27830CFS Applicator F/Supine Position F/Sealing F/Use W/Oper 1 27830H Grasping Forceps for Large Stone Frag. 3 Expanding Jaws 1 26160UHW Semi-Rigid Biopsy & Grasping Forceps w/ Double Action 1 27502 Luer-Lock Connector with Stopcock 2 393121J Tray, Percutaneous Nephroscopy Set 1

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