Product code NYS— General, Plastic Surgery

“A wound dressing with poly (diallyl dimethyl ammonium chloride) (pdadmac) additive is a device that is a sterile barrier wound dressing intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing. The device consists of a textile substrate and permanently bound pdadmac. The device acts as a physical barrier to outside contaminants and does not act on the surface or interior of the wound nor does it contain antimicrobial agents that act on the body.”

FDA has cleared 1 device under product code NYS, all in 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• Quick-Med Technologies, Inc.1 clearance

• DEN070002 — QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSINGQuick-Med Technologies, Inc.·2009-02-25