Sterilization and the efficacy of such have been r
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Posted On: 01/19/2024 9:24:42 AM
Sterilization and the efficacy of such have been reported today as favorable by CEO Brian Thom. Finally the pr we have been patiently waiting for!
United Health Products Reports on FDA Application Status
8:32 AM ET 1/19/24 | GlobeNewswire
United Health Products Reports on FDA Application Status
MESQUITE, NV, Jan. 19, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products (UEEC) reports today on the receipt and review of final reports on product sterilization and stability testing for its hemostatic gauze. As previously disclosed, UHP has been working with external packaging and sterilization service providers to complete various required tests for its Premarket Approval application. The reported data received this week on the efficacy of the proposed radiation sterilization protocol were well within acceptable bioburden levels for Class III products. UHP will now compile these data and proceed with final drafting of the PMA documentation to be submitted via the eSTAR platform for FDA and Health Canada review.
About United Health Products -- UHP develops, manufactures and markets HemoStyp(TM), a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
For more information on UHP visit the company's new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
United Health Products Reports on FDA Application Status
8:32 AM ET 1/19/24 | GlobeNewswire
United Health Products Reports on FDA Application Status
MESQUITE, NV, Jan. 19, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- United Health Products (UEEC) reports today on the receipt and review of final reports on product sterilization and stability testing for its hemostatic gauze. As previously disclosed, UHP has been working with external packaging and sterilization service providers to complete various required tests for its Premarket Approval application. The reported data received this week on the efficacy of the proposed radiation sterilization protocol were well within acceptable bioburden levels for Class III products. UHP will now compile these data and proceed with final drafting of the PMA documentation to be submitted via the eSTAR platform for FDA and Health Canada review.
About United Health Products -- UHP develops, manufactures and markets HemoStyp(TM), a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
For more information on UHP visit the company's new website: www.uhpcorp.com or contact the company at info@uhpcorp.com.
The company can also be reached by phone or text message at 475.755.1005.
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