QNS

Low Dead Space Needle, Single Lumen, Hypodermic

产品代码
QNS
器械名称
Low Dead Space Needle, Single Lumen, Hypodermic
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 880.5570
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)
3 件

FDA 分类定义

A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston syringe. It may or may not have needle safety features. The device can be used by health care professions or for self-injection by the patient.

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)(2 件)

数据窗口为最近三年。最新一件:2024-10-25。

510(k) 号批准日期申请人器械名称摘要
K2429562024-10-25Ocuject, LLCLDS Needle; OcuSafe® LDS Needle; SteriCap® LDS SafetPDF
K2317342024-03-08Tsk Laboratory International Japan KKSTERiJECT Low Dead Space, STERiJECT The Invisible NePDF

其中 2 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: QNS
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。