SDS

SDS Number: DK0002 Page 7 of 7
DAK CAUTION BULLETIN NO.1
DO NOT USE DAK MATERIALS IN MEDICAL APPLICATIONS INVOLVING PERMANENT, BRIEF,
OR TEMPORARY IMPLANTATION IN THE HUMAN BODY OR PERMANENT CONTACT WITH
INTERNAL BODY FLUIDS OR TISSUES, UNLESS THE MATERIAL HAS BEEN PROVIDED
DIRECTLY FROM DAK UNDER A CONTRACT WHICH EXPRESSLY ACKNOWLEDGES THE
CONTEMPLATED USE.
DAK MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY
CONCERNING THE SUITABILITY OF THESE MATERIALS FOR USE IN THE HUMAN BODY OR IN
CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES.
THE CONTENT OF DAK MATERIAL IS NOT CERTIFIED FOR IMPLANTS.
DAK materials are not designed or manufactured for use in implantation in the human
body or in contact with internal body fluids or tissues. DAK has not performed clinical
testing of these materials for implantation. DAK will not provide to customers making
implantable devices any notice concerning its materials, as specified under 21 CFR
section 820.50, or any other information necessary for medical device use of the
materials under any other statue or FDA regulation. DAK has neither sought, nor
received, approval from the FDA for the use of these materials in implantation in the
human body or in contact with internal body fluids or tissues.
ALL IMPLANTABLE MEDICAL DEVICES CARRY A RISK OF FAILURE AND ADVERSE
CONSEQUENCES
The medical judgment of a physician, a medical device seller and the FDA should be
relied upon for identification of both harmful consequences and life-saving benefits from
an implantation device comprised of specific materials. These benefits and risks can be
found in published medical cases performing clinical medical studies of an implantable
medical device. DAK does not support the use of its products in these applications and
cannot weigh the benefits against the risk defined in these articles. DAK can not offer a
medical judgment on the safety or efficacy of the use of its materials in such devices.
DO NOT MAKE REFERENCE TO THE DAK NAME OR ANY DAK TRADEMARK IN ASSOCIATION
WITH AN IMPLANTABLE MEDICAL DEVICE.
Do not use a DAK trademark or licensed trademark as the descriptive name of an
implantable medical device (e.g. do not call it the "Delcron®" prosthesis, or do not call it a
" Laser+® device”).
End of Bulletin