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OEM Supply of Dynamic Ankle Stabilizers

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 original equipment manufacture and supply of medical-grade dynamic ankle stabilizers for prime contractors supporting the Department of Defense Medical Supply Chain. The scope of work requires the production of latex-free braces in specific sizing, including Men's 9.5-11 and Women's 11-12.5, delivered in individually sealed commercial-grade packaging. To ensure quality and legality, the manufacturer must adhere to FDA Class I device regulations, maintain FDA registration, and ensure full GMP compliance. Additionally, the contract mandates strict adherence to Medical Marking Standard No. 1 and the Berry Amendment. Performance of this contract is associated with NAICS code 339113 and is managed under the Medical Supply Chain MD Surg FSF.

General Info

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

APO, AE, 09227-0000, USA

Set-Aside

NONE

Documents

This scope was carved out of SPE2DS-27-T-0487.

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 finished, medical-grade dynamic ankle stabilizers for prime contractors delivering DLA Troop Support Medical Supply Chain contracts. Manufactures latex-free braces for Men's sizes 9.5-11 and Women's 11-12.5 per FDA Class I device regulations. Requires FDA registration, GMP compliance, and adherence to Medical Marking Standard No. 1 and the Berry Amendment. Delivers individually sealed, commercial-grade packaged stabilizers.

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