Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

Code information: Model Number: 191-NRS. UDI-DI: 00821925003545. All lot numbers

Distribution pattern: International distribution to the country of Japan.