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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BIO-REACTOR ASSEMBLY; BIOREACTOR, APV, NO MESH; BOTTOM HEADER WITH STRAIGHT CONNECTOR; NO-MESH BAG ASSY, APV; SIP MANIFOLD SET N/S; TOP HEADER WITH 90 ΓΈ CONNECTOR; TUBING ASSEMBLY, 12 MANIFOLD,; TUBING ASSEMBLY, 12 MANIFOLD, CRYO, DG; TUBING ASSEMBLY, GROWTH FEED TREE, DG; TUBING ASSEMBLY, INOC MEDIA TREE, DG; TUBING ASSY, 4 MANIFOLD, CRYO, DG; TUBING ASSY, 4 MANIFOLD, MEDIA GROWTH, DG; TUBING ASSY, 8 MANIFOLD, CRYO, DG; TUBING ASSY, 8 MANIFOLD, MEDIA GROWTH, DG; TUBING ASSY, INOCULATION TREE, DG; TUBING ASSY, SIP
Classification Name: DRESSING, WOUND AND BURN, INTERACTIVE
Product Code: MGR
Device Class: 3
Registered Establishment Name: Sterigenics U.S., LLC
Registered Establishment Number: 2029275
Owner/Operator: Sterigenics International, LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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