Surgical Appliance and Supplies Manufacturing
Size Standard: 750 employees
NAICS code 339113 covers establishments primarily engaged in manufacturing surgical appliances and supplies. This includes orthopedic devices (splints, trusses, braces), surgical dressings, sutures, bandages, surgical sponges, personal safety equipment used in medical settings, and related disposable medical supplies.
Federal healthcare agencies consume enormous quantities of surgical supplies annually. The Department of Veterans Affairs operates 171 medical centers and over 1,000 outpatient sites, creating consistent demand for surgical appliances, wound care products, and orthopedic devices. Defense Health Agency (DHA) supports military treatment facilities worldwide and maintains readiness stockpiles.
Strategic National Stockpile (SNS) maintained by CDC and ASPR represents a unique procurement opportunity, as the government maintains supplies for emergency response. COVID-19 highlighted the importance of domestic manufacturing capabilities for personal protective equipment and surgical supplies.
Prosthetics and orthotics represent a growing segment, particularly for the VA's prosthetics program serving disabled veterans. The VA's Prosthetic and Sensory Aids Service (PSAS) purchases custom and off-the-shelf orthopedic devices, creating opportunities for specialized manufacturers.
Quality system compliance under FDA 21 CFR Part 820 and ISO 13485 certification are essential. Many government buyers prefer or require domestic manufacturing under the Berry Amendment and Buy American Act provisions, creating advantages for US-based manufacturers.
- Department of Veterans Affairs (VA)
- Defense Health Agency (DHA)
- Centers for Disease Control (CDC)
- Federal Emergency Management Agency (FEMA)
- Indian Health Service (IHS)
- Wound Care Supplies for VA Medical Centers
- Orthopedic Braces and Supports
- Surgical Dressings and Bandages
- Personal Protective Equipment (PPE)
- Prosthetic Components Manufacturing
These certifications can help you compete for set-aside contracts under NAICS 339113:
What products fall under NAICS 339113?
This code covers orthopedic devices (braces, splints, trusses), surgical dressings, sutures, bandages, surgical sponges, medical PPE, and disposable medical supplies. It excludes powered medical equipment and electronic devices.
What is the size standard for NAICS 339113?
The SBA size standard for NAICS 339113 is 750 employees, allowing many mid-sized manufacturers to qualify as small businesses for set-aside contracts.
How does the Berry Amendment affect this NAICS code?
The Berry Amendment requires DoD to purchase certain items, including medical supplies and textiles, from domestic sources. This creates advantages for US-based manufacturers of surgical supplies and dressings.
What emergency preparedness opportunities exist?
The Strategic National Stockpile and FEMA emergency preparedness programs purchase surgical supplies. COVID-19 increased focus on domestic manufacturing and stockpile replenishment, creating new opportunities.
What quality certifications are required?
FDA 21 CFR Part 820 compliance is mandatory for US sales. ISO 13485 is virtually required for government contracts. Some products require specific FDA clearances (510(k)) before marketing.
Businesses below this threshold in average annual receipts qualify as small businesses for set-aside contracts.
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