SBA Size Standard: NAICS 339112 Surgical and Medical Instrument Manufacturing — Small Business Threshold

SBA Description

Surgical and Medical Instrument Manufacturing

Receipts-Based Standard

Frequently asked questions

What is NAICS 339112?

NAICS 339112 is the North American Industry Classification System code for Surgical and Medical Instrument Manufacturing. It classifies this business activity for statistical, regulatory, and government procurement purposes. Federal agencies use NAICS codes to collect and publish data about the US economy, determine SBA size standards, and set aside contracts for small businesses.

What licenses and permits does a Surgical and Medical Instrument Manufacturing need?

A Surgical and Medical Instrument Manufacturing typically needs a local business license, a federal EIN from the IRS, and industry-specific permits depending on the sector. Check with your city or county clerk for a general business license, your state's professional or industry licensing board for any required occupational licenses, and your state's tax authority for a sales tax permit if you sell taxable goods or services.

How do I register a Surgical and Medical Instrument Manufacturing business in the United States?

To register a Surgical and Medical Instrument Manufacturing business, first choose your legal structure: sole proprietorship (simplest, uses SSN), LLC (personal liability protection, files with your Secretary of State), or corporation (Form 1120 or 1120-S). Register your business name (DBA) with your county if operating under a trade name. Obtain an EIN from the IRS at irs.gov/ein. Register with your state revenue department for any applicable taxes.

What tax forms does a Surgical and Medical Instrument Manufacturing file with the IRS?

Tax forms depend on your entity type. A sole proprietor files Schedule C with Form 1040 and Schedule SE for self-employment tax (15.3%). An LLC taxed as a partnership files Form 1065 with Schedule K-1s. A C-Corporation files Form 1120 (21% flat rate). An S-Corporation files Form 1120-S. All businesses paying employees file Form 940 (FUTA) annually and Form 941 quarterly. Estimated tax payments are made via Form 1040-ES four times per year.

Is Surgical and Medical Instrument Manufacturing the right NAICS code for my business?

Your NAICS code should reflect your primary business activity — the one generating the most revenue or value. If Surgical and Medical Instrument Manufacturing describes your main line of business, NAICS 339112 is likely correct. If you have multiple distinct activities, you may need separate codes for statistical reporting. For federal contracting, your SAM.gov registration should use the code that best matches the work you perform. Review the official NAICS 339112 description and exclusions to confirm it fits your operations.

What is a Business Associate Agreement (BAA) and does a Surgical and Medical Instrument Manufacturing need one?

A Business Associate Agreement (BAA) is a HIPAA-required contract between a covered entity and any vendor that creates, receives, maintains, or transmits protected health information (PHI) on their behalf. Common BAs include EHR vendors, billing services, cloud hosting, IT support, shredding services, and answering services. The BAA must specify permitted PHI uses, require BA to implement safeguards, report breaches, and ensure subcontractors also comply. BAAs are legally mandatory — working without one is a HIPAA violation.

What malpractice insurance does a Surgical and Medical Instrument Manufacturing need?

Medical malpractice (professional liability) insurance is not federally required but is mandatory for hospital privileges, many insurer credentialing panels, and in some states (e.g., Colorado, Connecticut, Kansas, Wisconsin) for specific professions. Policy types: claims-made (covers incidents reported while policy is active) vs. occurrence (covers incidents that happened during the policy period regardless of when claimed). Tail coverage is needed when canceling a claims-made policy. Limits typically range from $1M/$3M (per claim/aggregate) upward.

Does a Surgical and Medical Instrument Manufacturing need a DEA registration to prescribe medications?

Yes. Any healthcare provider who prescribes, administers, or dispenses controlled substances (Schedules II-V) must register with the DEA. Registration is by state and by business address. The application fee is $888 (3-year cycle). You need a valid state medical license first. DEA registration is location-specific — if you practice at multiple locations, you may need separate registrations. Starting 2023, new DEA registrants must complete 8 hours of opioid/substance use disorder training.

What telehealth rules apply to a Surgical and Medical Instrument Manufacturing?

Federal: Ryan Haight Act requires at least one in-person evaluation before prescribing controlled substances via telemedicine (with a COVID-era temporary waiver that has been partially extended). Medicare reimburses telehealth under specific conditions including geographic and originating site restrictions (some waived through 2024). State level: you must be licensed in the state where the patient is located. Most states now have telemedicine practice standards and require informed consent. Prescribing via telemedicine based solely on an online questionnaire is prohibited in most states.