The U.S. Food and Drug Administration granted 510(k) approval for Safe'n'Sound, a passive safety device for staked prefilled syringes. Rexam Healthcare is the processor of these devices.
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The fully passive Safe'n'Sound device provides protection against the risks of being pricked by a soiled needle, as the device comes with a protective sheath which activates automatically once the medicine has been administered.
This 510(k) approval allows Rexam to market in the United States.