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Miscellaneous

Certifications and Registrations

The OnePacs System is 510(k) cleared by the US Food and Drug Administration as a class II medical device. OnePacs satisfies the requirements of the FDA for manufacturers of Class II devices, including Establishment Registration, Device Listing, U.S. Agent and Quality Systems (QS) regulation (21 CFR Part 820), and other regulations.

The OnePacs system is cleared for medical use in Brazil under the ANVISA program.

O sistema OnePacs é aprovado pela ANVISA para uso clínico no Brasil.

We self-certify compliance with:

Caution: The OnePacs system as deployed for clinical use is a registered/licensed medical device. Educational and Research versions of the OnePacs system are neither intended nor licensed for clinical use, and should only be used as permitted by applicable and governing regulations.

Notice for users within the United States:

Caution: The OnePacs system as deployed for clinical use is For Prescription Use Only (US Regulation 21 CFR 801.109). Federal law restricts this device to sale by or on the order of a physician.

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