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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: AMS 800 Urinary Control System
Classification Name: DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC
Product Code: EZY
Device Class: 3
Regulation Number: 876.5280
Medical Specialty: Gastroenterology
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1450293
Owner/Operator: Sterigenics International, Inc.
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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