PDK
- 产品代码
- PDK
- 器械名称
- Cream For X-Ray Attenuation
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 892.6510
- FDA 专业组
- Radiology
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- FDA 历史累计 510(k)
- 2 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
The x-ray attenuating cream is intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a gloved hand, followed by donning a second glove. The X-ray attenuating cream is intended to be used during medical procedures where its necessary for hands to be exposed to radiation to offer some degree of protection from radiation exposure.
FDA 官方分类页： PDK
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。