PEB
- 产品代码
- PEB
- 器械名称
- Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 884.5300
- FDA 专业组
- Obstetrics/Gynecology
- 上市路径
- 需提交 510(k) 上市前通告
- FDA 历史累计 510(k)
- 10 件（全部年份；本站只收录近三年的明细）
FDA 分类定义
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
FDA 官方分类页： PEB
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。