PuraDERM凝胶
K号: K193085 · 2020-05-11
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器械摘要
PuraDERM Gel is the device name listed in this FDA 510(k) record. The listed applicant is 3-D Matrix, Inc.. It received FDA 510(k) clearance on 2020-05-11 under 510(k) number K193085. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the PuraDERM Gel?
PuraDERM Gel is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is 3-D Matrix, Inc.. The 510(k) number is K193085.
When did PuraDERM Gel receive FDA 510(k) clearance?
PuraDERM Gel received FDA 510(k) clearance on 2020-05-11, under 510(k) number K193085.
Who is the listed applicant for PuraDERM Gel?
FDA 510(k)记录显示3-D Matrix，Inc.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for PuraDERM Gel?
The FDA product code for PuraDERM Gel is FRO. This falls under the Anesthesiology category.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
列明3-D Matrix, Inc.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：FRO）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K254168Actolind®（06.3637. Actolind®凝胶加强型）ACTO GmbHK254041SkinSmart 抗菌保湿凝胶Magic Science Supply, LLCK261646Redermax® 抗菌伤口基质Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLCK251929SilverCeuticals® 抗菌伤口凝胶Silverceuticals, Inc.K261023Microdacyn 伤口冲洗溶液Sonoma Pharmaceuticals, Inc.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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