a511b3bd-3c12-44b8-b293-a071f493401fUpdatePublished32020-08-262016-11-302020-08-25Not in Commercial Distribution20326053106921PackageGS11032605310692422020-08-25Not in Commercial Distribution10326053106924PrimaryGS1Regard™OR0345945020902RESOURCE OPTIMIZATION & INNOVATION, L.L.C.1falsetruefalsetruefalsetruetruefalsefalsetruefalsefalsefalseMR Safetruefalse44096Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.falseActiveFDELaparoscopy Kittruefalse