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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: BG3500 12mm Spreader Tip; BG3500 16mm Spreader Tip; BG3500 Mixing Tip; BG3502 BioGlue 2 mL; BG3510 BioGlue 10 mL; BG3515 BioGlue 5 mL
Classification Name: GLUE,SURGICAL,ARTERIES
Product Code: MUQ
Device Class: 3
Registered Establishment Name: ISOMEDIX OPERATIONS INC.
Registered Establishment Number: 1047843
Owner/Operator: STERIS Corporation
Owner/Operator Number: 1527821
Establishment Operations: Contract Sterilizer
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