NYS

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

产品代码

NYS

器械名称

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

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.4015

FDA 专业组

General, Plastic Surgery

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。