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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Fully Automatic Biopsy Gun; MRI/Conv. Fully Automatic Biopsy Set; MRI/Conv. Semi Automatic Biopsy Set; Needle Block; Needle Sleeve; Semi Automatic Biopsy Gun
Classification Name: INSTRUMENT, BIOPSY
Product Code: KNW
Device Class: 2
Regulation Number: 876.1075
Medical Specialty: Gastroenterology
Registered Establishment Name: Sterigenics U.S. LLC
Registered Establishment Number: 1054811
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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