FDA product code NYS: Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

NYS is the FDA product code for wound dressing with poly(diallyl dimethyl ammonium chloride)(pdadmac). It is a Class II device, regulated under 21 CFR 878.4015 and reviewed by the General and Plastic Surgery panel. Devices under NYS reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for NYS devices

openFDA lists no recalls for product code NYS.

Frequently asked questions

What is FDA product code NYS?

NYS is the FDA product code for wound dressing with poly(diallyl dimethyl ammonium chloride)(pdadmac). It is a Class II device, regulated under 21 CFR 878.4015 and reviewed by the General and Plastic Surgery panel.

What device class is NYS?

Class II, regulation 21 CFR 878.4015. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code NYS
• Run a recall and safety report across every NYS manufacturer
• Watch product code NYS for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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