NYS

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Device class

Class II (moderate risk)

Regulation

21 CFR 878.4015

Medical specialty

General, Plastic Surgery

FDA definition

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.

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