inforMED
NYSClass II

Wound Dressing With Poly(diallyl Dimethyl Ammonium Chloride)(pdadmac)

General, Plastic Surgery · 21 CFR 878.4015

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.

MDR events0All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time

Recent MDR events

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Event type breakdown

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Registered firms

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