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Manufacturer of FDA-Regulated Ankle Braces

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This subcontract involves the manufacture and supply of 32 units of medical-grade ankle braces for prime contractors supporting DLA Troop Support Medical Supply Chain projects. The devices must be produced according to NSN 6515-01-699-6619 and strictly adhere to FDA Regulation 890.3475 and Good Manufacturing Practices. Performance will take place at Camp Lejeune, with the products classified as FDA-regulated Class I medical devices. To be eligible, the provider must maintain active FDA registration and listing while ensuring full compliance with Berry Amendment domestic sourcing requirements. The opportunity is categorized under NAICS code 339113 and is managed through the Department of Defense. Interested parties must submit their responses by November 9, 2026.

General Info

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

CAMP LEJEUNE, NC, 28542-0128, USA

Set-Aside

NONE

Documents

This scope was carved out of SPE2DS-27-T-1223.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

BRACE, ANKLE

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Defense → MEDICAL SUPPLY CHAIN MD SURG FSF
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Supplies medical-grade ankle braces for prime contractors on DLA Troop Support Medical Supply Chain projects. Manufactures braces per NSN 6515-01-699-6619 in compliance with FDA Regulation 890.3475 and Good Manufacturing Practices (GMP). Requires FDA registration, listing, and Berry Amendment domestic sourcing compliance. Delivers 32 units of FDA-regulated Class I medical devices.

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