Splinter Out is steam autoclave sterilized and meets all the specifications of the United States Government FDA. "CE" marked and compliant with the European Medical Devices Directive ISO 13485:2003, Splinter Out is certified for "CE" marking by the European Common Market. It complies completely with the European Medical Devices Directive 93/42/EEC and EN46002:1996 as well as the United States FDA Good Manufacturing Practice Regulations. It also complies with Health Canada’s CMDCAS requirements. Splinter Out is manufactured entirely in the U.S.A. in MEDIpoint’s certified ISO 9001:2008 facility.