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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: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (CRT-D)
Product Code: NIK
Device Class: 3
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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