- Enables COVID-19 sample collection
- 1 box of 250 swabs individually packed in sterilization pouches ready for sterilization
- Swabs designed by USF Health's 3D Clinical Applications Division and Northwell Health
- Swabs tested by Northwell Health, USF Health, and Tampa General Hospital - have cleared all testing hurdles
- 3D Printed in a FDA-registered, DAMAS-certified facility
- Made in America
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NP swabs are flexible sticks with a bristled end that are inserted into the nostril to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles.
ROE Dental Laboratory has partnered with Formlabs (using a patented design from USF Health and Northwell Health) to become a contract provider of 3D printed alternative Nasopharyngeal test swabs.
ROE has been granted a production license for these swabs and is ready to immediately produce them in their FDA-registered, DAMAS-certified facility in Independence, Ohio.
The nasal swabs have cleared all testing hurdles and are now being produced. All testing by these institutes showed that the 3D printed nasal swabs perform equally to standard swabs used for testing of COVID-19.
NP swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR § 880.6025. FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR § 807.20.
Disinfection and Sterilization Instructions
- The swab may be cleaned, disinfected, and sterilized according to facility protocols. Tested methods of disinfection include: soaking the finished swab in fresh 70% IPA for 5 minutes. Note: Do not leave the part in an alcohol solution for an extended period.
- Swabs may be steam sterilized according to CDC recommended cycles (132 °C / 270 °F for 4 minutes in a pre-vacuum steam sterilizer or 30 minutes at 121 °C / 250 °F in a gravity displacement autoclave), or according to facility/autoclave manufacturer’s protocols, as long as the cycle does not exceed 20 minutes for 134 °C / 273 °F or 30 minutes at 121 °C / 250 °F.
- Autoclave cycles should include a dry cycle to best maintain accuracy. For example, wrapped instruments sterilized in a prevacuum autoclave should be dried for 20-30 minutes according to CDC recommendations. Longer or hotter autoclave cycles than those listed above may result in degradation of physical properties and accuracy. Note: A color shift will be observed after autoclaving, this is normal.
- After disinfection and sterilization inspect the swab for cracks to ensure the integrity of the swab.
Made in America.
If you are not completely satisfied with your non-custom purchase, please contact us to return or exchange your item(s) within 30 days of the delivery date, with proof of purchase. Note that returns or exchanges are not accepted for custom orders, such as dental prosthetics, which are subject to the the terms of our warranty policy. Items must be in their original packaging, and if a medical product unopened. Upon return, your item will be inspected, and exchanges, credits or refunds will be issued for the purchase price. Any taxes charged will be refunded in accordance with applicable laws. Delivery fees are non-refundable with the exception of manufacturer defects or transit damage. ROE reserves the right to refuse returns or exchanges of items that are not in as-new condition due to damage or misuse by the client.
For all orders that are canceled prior to items shipping, no delivery fee will be charged, and the item will be credited in full. For special orders or custom orders such as dental prosthetics, all costs incurred by ROE for the return will be charged or the work completed up to the time of the cancellation will be charged prorated from the initial purchase price.
PRICING & INFORMATION DISCLAIMER
Our goal is to provide accuracy in all prices, delivery rates and other information. All prices printed and online are in U.S. dollars and are subject to any applicable taxes according to state and local laws. Availability, prices and delivery rates are subject to change. There may be errors in the prices, descriptions or images of certain merchandise, and we reserve the right to cancel orders if such errors, inaccuracies or omissions are discovered.
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