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 a single unit of an Eye Occluder, model PLAS250MM LG PLAIN HNDLE SINGLE-ENDED 70MM RAD CUP, with NSN 6540010775405 and part numbers 12113 and W0-204 from GULDEN OPHTHALMICS INC. and WESTERN OPHTHALMICS CORP. The item is classified as a Class II medical device regulated by the FDA, requiring compliance with 510(k) and additional marketing requirements including registration, labeling, and GMP standards. Delivery is due within 20 days FOB destination, with zero tolerance for quantity variance, and inspection and acceptance occur at the delivery point. Packaging must conform to Medical Marking Standard No. 1, superseding MIL-STD-129, and must ensure protection from damage during transit, with exterior shipping containers selected to enable safe and cost-effective delivery via common carrier. All packaging and labeling must follow ASTM D3951 unless superseded by DLA Master List Technical and Quality Requirements, and palletization must adhere to DLA Packaging Requirements. Shipment must be made by the fastest traceable means, excluding parcel post, to the vessel shipment address for USS RONALD REAGAN CVN 76. The contract references specific DLA procedural notes and requires the bidder to provide full manufacturer and product details to the contracting official for FDA referral prior to award.
General Info
Agency
NAICS
Place of Performance
UNIT 100197 BOX 1, FPO, AP, 96616, 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-309E
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 7017735397 0001 EA 1.000
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-QUP:001
WILL BE PACKAGED IN ACCORDANCE WITH ASTM D3951.
All DLA Master List of Technical and Quality Requirements take precedence over ASTM D3951. Mark and label all packaging and packing in accordance with MIL-STD-129. The Unit of Issue (U/I) and Quantity per Unit Pack (QUP) will be as specified in the contract/purchase order. PALLETIZATION SHALL BE IN ACCORDANCE WITH RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
PARCEL POST ADDRESS:
R22178
USS RONALD REAGAN CVN 76
UNIT 100197 BOX 1
FPO AP 96616
US
VESSEL SHIPMENT. TRANSPORTATION SEE DLAD PROC NOTE C19. FIRST DESTINATION TRANSPORTATION SEE DLAD PROC
NOTE C20 AND CONTRACT
FREIGHT SHIPPING ADDRESS:
R22178
USS RONALD REAGAN CVN 76
DLA VENDORS: USE VSM FOR
US
SPE2DS-26-T-309E
SECTION B
PR: 7017735397 PRLI: 0001 CONT’D
RDD 777 SHIPMENT. SHIP BY FASTEST TRACEABLE MEANS. DO NOT USE PARCEL POST.
M/F: (TCN) R221786208P178
RDD: 777
PROJ: EP5 TP 2
SUPP ADD: SIG: A
FOR GOVERNMENT USE ONLY: (IPD) 06
DIC: A4A DIST: 9B ADV: 2A FC: L7
Need Ship Date:00/00/0000 Original Required Delivery Date:08/06/2026
SPE2DS-26-T-309E NSN/Part Number: 6540-01-077-5405 Quantity: 1 EA Purchase Request: 7017735397QTY: 1 Delivery: 20 days ADO
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