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NOTICE OF INTENT TO INCREASE QUANTITIES OF LASER TREATMENT CARDS VIA MODIFICATION TO EXISTING INDEFINITE DELIVERY INDEFINITE QUANTITY (IDIQ) : N626454-11-D-5050

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N6264511D5050Federal

Contract Overview

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AI Contract Overview

The Naval Medical Logistics Command seeks to increase the quantities of laser treatment key cards, specifically for AMO’s 10TX – Addedvue Pak High Myopia Domes, 10TX – S4 USA LASIK PRK ASTIG, and IFLAP US products, manufactured by Abbott Medical Optics. This increase of 400 units will be added to an existing indefinite delivery, indefinite quantity contract (IDIQ N626454-11-D-5050). These key cards are proprietary components essential for operating VISX Photo Refractive Keratectomy (PRK) systems used at various medical facilities to perform precise and delicate eye surgeries, including treatments for myopia, hyperopia, astigmatism, high myopia, and LASIK flap creation. The contract requires all components and systems to comply with FDA regulations for marketing and delivery of medical products in the U.S., regardless of where the product is ultimately delivered. Installation must also adhere to OSHA standards. The procurement falls under the NAICS code 339115, indicating a focus on surgical and medical instrument manufacturing. Interested parties capable of meeting these requirements were invited to submit capability statements by September 21, 2012. The contract is managed by the Naval Medical Logistics Command, located in Fort Detrick, Maryland.

General Info

Naval Medical Logistics Command orders 400 FDA-compliant laser treatment key cards for eye surgery.

Agency

Department Of Defense → Naval Medical Logistics Command

NAICS

339115 - Ophthalmic Goods Manufacturing

Place of Performance

Set-Aside

NONE

Documents

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Timeline

PostedAug 22

special-notice

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Organization & Contact Information

AgencyDepartment Of Defense → Naval Medical Logistics Command

ContactsNo contacts available

OfficeFORT DETRICK, MD, 21702-9203, USA

Organization / AgencyDepartment Of Defense → Naval Medical Logistics Command

Office AddressFORT DETRICK, MD, 21702-9203, USA

ContactsNo contact information available

Full Description

DEPARTMENT OF THE NAVY NAVAL MEDICAL LOGISTICS COMMAND NOTICE OF INTENET TO SOLE SOURCE The Naval Medical Logistics Command intends to increase the quantities on CLIN 0004 of AMO’s 10TX – Addedvue Pak High Myopia Domes, AMO’s 10TX – S4 USA LASIK PRK ASTIG and AMOS’s IFLAP US which are all manufactured by Abbott Medical Optics (AMO) (AMO), 1700 E. St. Andrew Place, Santa Ana, CA 92705, on an existing Indefinite Delivery Indefinite Quantity (IDIQ) : N626454-11-D-5050. The quantity will be increased by 400 units. This procurement will be classified under North American Industry Classification System (NAICS) 339115. Essential Characteristics: The requirement is to add treatment key cards for use with various facilities’ VISX Photo Refractive Keratectomy (PRK) systems. These PRK systems are used to perform fragile procedures on the eye. Each key card shall provide the proprietary information needed to perform a procedure on the key using the VISX systems mentioned below already located at those facilities. These procedures shall include the following: laser treatment for eye ablation to treat myopia, hyperopia, mixed astigmatism treatment, and high myopia treatment for Lasik; laser treatment for ablation of the surface of the eye; and flap creation for use during Lasik surgical procedures. 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. The system shall be installed in compliance with OSHA requirements. IF YOU CAN SATISFY THIS REQUIREMENT, PLEASE SUBMITT YOUR CAPABILITIES STATEMENTS TO contact@example.gov NO LATER THAN 4:30 ON FRIDAY, 21 SEPTEMBER 2012.

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