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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Dextrus; EFH; Selox; Setrox S; Tilda
Classification Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELECTRODES
Product Code: NVN
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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