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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Essure
Classification Name: INSERT, TUBAL OCCLUSION
Product Code: HHS
Device Class: 3
Regulation Number: 884.5380
Medical Specialty: Obstetrics/Gynecology
Registered Establishment Name: BAYER HEALTHCARE LLC
Registered Establishment Number: 2951250
Owner/Operator: Bayer HealthCare Pharmaceuticals Inc.
Owner/Operator Number: 10045903
Establishment Operations: Manufacturer; Repackager/Relabeler; Reprocessor of Single Use Devices; Complaint File Establishment