SHM

Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

产品代码

SHM

器械名称

Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 880.6891

FDA 专业组

General Hospital

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

1 件

FDA 分类定义

An interim reprocessing cleaning and intermediate-level disinfection wipe is intended for use by a health care provider to clean and intermediate-level disinfect medical device types indicated on the labeling as an interim step prior to sterilization or high-level disinfection. This is intended as a non-terminal disinfection step compatible with subsequent terminal reprocessing such as sterilization or high-level disinfection and renders the device safe to handle by the user compared to unprocessed, clinically soiled devices. “Safe to handle” is limited in scope to mean the device has been appropriately intermediate-level disinfected.

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）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2026-05-01。