Expanding and wound protection instruments
- Analysis ID
- 230002911/PCBB-HN
- Submission ID
- 000.00.19.H26-231030-0025
- Product Type
- Alexis Laparoscopic System
- Product Code
- C8501; C8502
- Manufacturer
- Applied Medical Resources Corporation
- Intended Use
- The Alexis O surgical instrument for protecting the surgical site/ dilating the surgical site allows the surgeon to access the abdominal cavity through the incision, enabling maximum exposure with the minimum size of the incision. In addition to dilating the incision, it also provides protection against infection of the incision site in both open and laparoscopic surgery. The Alexis O surgical instrument for protecting the surgical site/ dilating the surgical site can be used to access the thoracic cavity or other soft tissue in cardiac and general surgery. The laparoscopic closure cap is used in laparoscopic surgery to close the incision or to reposition the incision as an additional port for the 12mm trocar.
- Registration Date
- Nov 06, 2023
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Access comprehensive regulatory information for Expanding and wound protection instruments in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230002911/PCBB-HN and manufactured by Applied Medical Resources Corporation.
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