The company says the approval makes DuraBlue the only dual-layered sterilization wrap where the entire product line has longer-than 30-day sterility maintenance test data cleared by the FDA.
The updated sterility maintenance indications are based on validation of wrap sterilized through the Johnson & Johnson STERRAD 100S and STERIS Amsco V-PRO systems.
“We understand how important extended sterility maintenance testing is to our customers, and we pursued this testing out of our dedication to product quality and performance,” said Lisa Ashby, president, category management at Cardinal Health, in the release.
DuraBlue sterilization wrap now has FDA clearance for pre-vacuum steam, ethylene oxide, Johnson & Johnson STERRAD 100S and all cycles of the STERIS Amsco® V-PRO 1, 1 Plus and maX sterilization systems.
Cardinal Health is headquartered in Dublin, Ohio.
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