- Additional Info
Splinter Out’s are steam autoclave sterilized, meeting all specifications of the United States Government FDA. They are "CE" marked in compliance with the European Medical Devices Directive ISO 13485:2003. Splinter Out’s are certified for "CE" marking by the European Common Market. They comply completely with the European Medical Devices Directive 93/42/EEC and EN46002:1996 as well as the United States FDA Good Manufacturing Practice Regulations. They also comply with Health Canada’s CMDCAS requirements. Splinter Out is manufactured entirely in the U.S.A.