The Storch-Murphy Group (908) 276-0777 firstname.lastname@example.org
FOR IMMEDIATE RELEASE
TERUMO MEDICAL CORPORATION ANNOUNCES FDA 510K CLEARANCE OF THE K-PACK SURSHIELDTM HYPODERMIC NEEDLE WITH INTEGRATED PASSIVE SHARPS PROTECTION
New Package Design Allows Fully Automated Secondary Packaging Of Parenteral Medication Within Optimized Space Requirements Inside The Secondary Container
SOMERSET, NJ (September 14, 2011)— Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, today announced receipt of 510k clearance from the U.S. Food & Drug Administration to market the new K-Pack SurshieldTM hypodermic needle featuring integrated, passive sharps protection for use with pre- filled syringes for intramuscular and subcutaneous pharmaceutical applications.
The K-Pack Surshield comes individually packaged and sterile in a rigid container with a tamper-evident and color-coded label. Initially, U.S. customers will have access to the K-Pack Surshield with Terumo’s high- quality 25-gauge needle designed for minimal patient trauma. However, Terumo has already applied for 510k clearance of its smaller 27-gauge needle. The K-Pack Surshield 25-gauge needle has CE Mark approval for marketing outside the U.S., while the 27-gauge device is currently in the CE Marking approval process.
“Terumo’s innovative K-Pack Surshield offers exceptional performance and safety for the healthcare professional,” said Juichi (Jim) Takeuchi, President and CEO, Terumo Medical Corporation. “However, it is the truly unique packaging that distinguishes this device from all other competitive platforms. Our deeper understanding of industry needs allowed us the insight to specifically design the K-Pack Surshield so that our pharmaceutical customers can fully automate packaging processes for secondary packaging of parenteral medication with minimum space requirements of the secondary packaging.”
For more information on K-Pack SurshieldTM, please contact Reagan Broussard, Manager, Corporate Accounts, Global Pharmaceutical Solutions, Terumo Medical Corporation, at (214) 912-4218 or email email@example.com.