QJT
- 产品代码
- QJT
- 器械名称
- Rigid Sterilization Container With Software
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.6855
- FDA 专业组
- General Hospital
- 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
The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems.
FDA 官方分类页： QJT
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。