NQB

Conformer, Ophthalmic, Biological Tissue

产品代码
NQB
器械名称
Conformer, Ophthalmic, Biological Tissue
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 886.3130
FDA 专业组
Ophthalmic
上市路径
豁免 510(k)(仍须遵守通用控制与注册列名)
标记
属植入器械
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 ophthalmic conformer with molded plastic and biological tissue insert is introduced temporarily between the eyeball and eyelid to maintain space in the orbital cavity, prevent closure or adhesions during the healing process following surgery, and enables positioning of biological tissue to the ocular surface without the need for sutures.

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)。

FDA 官方分类页: NQB
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。