OCE

Cultured Epithelial Autograft

产品代码

OCE

器械名称

Cultured Epithelial Autograft

管理类别

第 F 类（HDE）

FDA 专业组

Unknown

上市路径

HDE - Humanitarian Device Exemption

标记

属植入器械

标记

属生命支持/维持器械

FDA 分类定义

Interactive wound and burn dressing containing a live xenogeneic component. Indicated for use in patients who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

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）。