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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 500-001 12 Fr SLS; 500-012 14 Fr SLS; 500-013 16 Fr SLS; 500-301 12 Fr GLIDELIGHT; 500-302 14 Fr GLIDELIGHT; 500-303 16 Fr GLIDELIGHT
Classification Name: DEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
Product Code: MFA
Device Class: 3
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 1721676
Owner/Operator: Sterigenics International, Inc.
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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