OCCLUDER, EYE
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract specifies the procurement of an eye occluder, identified by part number P/N 12113 from GULDEN OPHTHALMICS INC. and P/N W0-204 from WESTERN OPHTHALMICS CORP, with the NSN 6540-01-077-5405. The device is classified as a FDA-regulated Class II medical device requiring a 510(k) submission and compliance with additional marketing requirements including registration, labeling, and GMP standards. A total of four units are to be delivered under purchase request 7017700397, with a unit price of $4.00 and a total value of $16.00. Delivery is required FOB destination within 20 days, with no variance allowed in quantity, and inspection and acceptance occur at the delivery point. All packaging must comply with Medical Marking Standard No. 1, superseding MIL-STD-129, and must use sealed unit containers to protect against damage, with commercial exterior shipping containers suitable for safe and cost-effective carrier delivery. Packaging must also meet MIL-STD-2073-1E, and all items must be marked in accordance with DLA requirements. The solicitation, issued under SPE2DS-26-T-300M, has a response deadline of August 10, 2026, and is managed by the Department of Defense’s Medical Supply Chain MD Surg FSF, with delivery targeted to Fort Campbell, 42223-5349.
General Info
Agency
NAICS
Place of Performance
2434 20TH STREET, FORT CAMPBELL, KY, 42223-5349, USSet-Aside
Documents
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Full Description
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS
SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
OCCLUDER, EYE OCCLUDER EYE PLAS250MM LG PLAIN HNDLE SINGLE-ENDED 70MM RAD CUP
UNIT OF ISSUE: EACH (EA)
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS (IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
This device or drug is regulated by the FDA. Note to Buyers: The contracting official shall send a referral in EBS to the product specialist for confirmation. Please include bidder name and bidder contact information, manufacturer name, manufacturer part number, and item description. REGULATION 886.3320 CLASS II EVEN THOUGH A 510(K) IS REQUIRED, IT IS NECESSARY TO MEET OTHER REQUIREMENTS FOR MARKETING. THESE INCLUDE:
SPE2DS-26-T-300M
SECTION B
REGISTRATION AND LISTING, LABELING OR GMP'S.
GULDEN OPHTHALMICS INC. 94370 P/N 12113
WESTERN OPHTHALMICS CORP 1GYB0 P/N W0-204
DLA issues this document using the DoD authorized unit of issue, please refer to the following URL to determine the corresponding ANSI X12 unit of issue.
https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.dla.mil%2FPortals%2F104%2FDocuments% 2FDLMS%2FeApplications%2FLogDataAdmin%2FUnitofIssueandPurchaseUnit.xlsx&wdOrigin=BROWSELINK
CLIN PR PRLI UI QUANTITY UNIT PRICE TOTAL PRICE.
0001 7017700396 0001 EA 4.000
NSN/MATERIAL:6540010775405
DELIVERY (IN DAYS):0020
DELIVER FOB: DESTINATION
QTY VARIANCE: PLUS 0% MINUS 0%
INSPECTION POINT: DESTINATION
ACCEPTANCE POINT: DESTINATION
PREP FOR DELIVERY:
PKGING DATA MIL-STD-2073-1E
SPECIAL NSN/Part Number: 6540-01-077-5405 Quantity: 4 EA Purchase Request: 7017700397QTY: 2 Delivery: 20 days ADO
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