Cardinal Health灭菌包装
K号: K161910 · 2017-04-20
广告
决定日期2017-04-20
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
Cardinal Health Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K161910. 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 Cardinal Health Sterilization Wrap?
Cardinal Health Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K161910.
When did Cardinal Health Sterilization Wrap receive FDA 510(k) clearance?
Cardinal Health Sterilization Wrap received FDA 510(k) clearance on 2017-04-20, under 510(k) number K161910.
Who is the listed applicant for Cardinal Health Sterilization Wrap?
The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cardinal Health Sterilization Wrap?
The FDA product code for Cardinal Health 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Cardinal Health200, LLC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。
K241780Cardinal Health 氮化橡胶检查手套K230838Cardinal Health™ SmartGown™ EDGE透气手术服，带ASSIST™工具口袋K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)K230028Kendall SCD SmartFlow 控制器，Cardinal Health Element 空气袖，Kendall SCD Express 空气袖，Kendall SCD Express 足部袖，Kendall SCD 顺序压缩舒适袖，Kendall SCD SmartFlow 控制器管路组件K201592Cardinal Health Protexis PI Blue with Neu-Thera 手术手套K211390乳胶蓝无粉检查手套
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。
广告