FDA 510(k)

BeneHold外科切口巾，含CHG抗菌劑

K 號：K202208 · 2021-07-30

決定日期2021-07-30

產品代碼KKX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

BeneHold Surgical Incise Drape with CHG antimicrobial is the device name listed in this FDA 510(k) record. The listed applicant is Avery Dennison Belgie Bvba. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K202208. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BeneHold Surgical Incise Drape with CHG antimicrobial?

BeneHold Surgical Incise Drape with CHG antimicrobial is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Avery Dennison Belgie Bvba. The 510(k) number is K202208.

When did BeneHold Surgical Incise Drape with CHG antimicrobial receive FDA 510(k) clearance?

BeneHold Surgical Incise Drape with CHG antimicrobial received FDA 510(k) clearance on 2021-07-30, under 510(k) number K202208.

Who is the listed applicant for BeneHold Surgical Incise Drape with CHG antimicrobial?

The FDA 510(k) record lists Avery Dennison Belgie Bvba as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeneHold Surgical Incise Drape with CHG antimicrobial?

The FDA product code for BeneHold Surgical Incise Drape with CHG antimicrobial is KKX.

其他以 Avery Dennison Belgie Bvba 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170407BD ChloraShield I.V. 製片含 CHG 抗菌劑

相關器械（代碼：KKX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230645BeneHold™ 外科切口覆蓋布，配CHG抗菌II型Avery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K200238ControlRad 無菌蓋Controlrad, Inc.K163556MediClear 預手術Covalontechnologies, Inc.

官方來源

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