灭菌包装
K号: K222151 · 2023-03-23
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决定日期2023-03-23
产品代码FRG
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Kenpax International Limited. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222151. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Sterilization Wrap?
Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2023-03-23. The listed applicant is Kenpax International Limited. The 510(k) number is K222151.
When did Sterilization Wrap receive FDA 510(k) clearance?
Sterilization Wrap received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222151.
Who is the listed applicant for Sterilization Wrap?
The FDA 510(k) record lists Kenpax International Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sterilization Wrap?
The FDA product code for Sterilization Wrap is FRG.
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Kenpax International Limited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：FRG）
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。
K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术O&M Halyard, Inc.K252823Dukal 烫金纸灭菌包装Dukal, LLCK253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹O&M Halyard, Inc.K251347灭菌袋/卷Sterivic Medical Co., Ltd.K251177自封灭菌袋和卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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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