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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Dextrus; Selox; Setrox S; Tilda
Classification Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
Product Code: DXY
Device Class: 3
Regulation Number: 870.3610
Medical Specialty: Cardiovascular
Registered Establishment Name: BIOTRONIK AG
Registered Establishment Number: 8043892
Owner/Operator: BIOTRONIK AG
Owner/Operator Number: 10024585
Establishment Operations: Contract Manufacturer; Contract Sterilizer
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