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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 0.9 EXTREME ELCA; 0.9 EXTREME, 80/80 ELCA; 0.9 VITESSE ELCA; 0.9 VITESSE, 80/80 ELCA; 1.4 VITESSE-COS ELCA; 1.7 VITESSE-COS; 1.7 VITESSE-EII ELCA; 2.0 VITESSE-COS ELCA; 2.0 VITESSE-EII ELCA
Classification Name: DEVICE, ANGIOPLASTY, LASER, CORONARY
Product Code: LPC
Device Class: 3
Registered Establishment Name: Terumo BCT STERILIZATION SERVICES, Inc.
Registered Establishment Number: 1724474
Owner/Operator: Terumo BCT, INC.
Owner/Operator Number: 9002708
Establishment Operations: Contract Sterilizer
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