NNH

Needle, Conduction, Anesthesia, Reprocessed

产品代码

NNH

器械名称

Needle, Conduction, Anesthesia, Reprocessed

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 868.5150

FDA 专业组

Anesthesiology

上市路径

需提交 510(k) 上市前通告

标记

可走第三方审查

FDA 分类定义

A reprocessed needle is a device used to inject local anesthesia into a patient to provide regional anesthesia. This is the same as "BSP." Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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）。