Device Dossier
ETHICON™ 3D Reload - Surgical staple, non-bioabsorbable
Device Dossier for ETHICON™ 3D Reload - Surgical staple, non-bioabsorbable (Surgical staple, non-bioabsorbable, Class III, sponsor Johnson & Johnson…
- GMDN category: Surgical staple, non-bioabsorbable
Intended purpose
The ETHICON™ 3D Reloads and ETHICON™ 4000 Staplers are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen
Functional description
ETHICON™ 3D Reload is loaded into ETHICON™ 4000 Stapler for stapling. Available in White reload color for vascular use, it consist of 6 staggered rows of staples, three on either side of the cutline, and when fired, delivers 3D staples in the 1st, 2nd, 5th, and 6th rows of staples and 2D staples in the 3rd and 4th rows (nearest to the cutline). There are 88 staples in 60mm length reload with closed staple height of 1.0mm. The staples are permanent implants to provide tissue closure & apposition.