16022c8f-511e-431d-ac7e-918cbcee8774UpdatePublished62022-06-172015-09-012019-08-22Not in Commercial Distribution20705031015095PackageGS11070503101509852019-08-22Not in Commercial DistributionBX10705031015098PrimaryGS1E-PACK8398E8398E002144145ETHICON INC.1E-Pack Procedure KitfalsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(877)384-4266xxx@xxx.xxx33961General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.falseActiveGAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACIDtruefalse