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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: INTEGRA
Classification Name: LITHOTRIPTOR, EXTRACORPOREAL SHOCK-WAVE,UROLOGICAL
Product Code: LNS
Device Class: 2
Regulation Number: 876.5990
Medical Specialty: Gastroenterology
Registered Establishment Name: DIREX SYSTEMS CORP.
Registered Establishment Number: 1224828
Owner/Operator: DIREX SYSTEMS CORP.
Owner/Operator Number: 9024470
Establishment Operations: Manufacturer
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