EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Unit. Arab Emir.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1081-2022