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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: CardioGenesis SoloGrip III Handpiece; CardioGenesis; Pearl 5.0 handpiece and SoloGrip III handpiece; Transmyocardial Laser Revascularization Handpiece PEARL 5.0; Transmyocardial Laser Revascularization Handpiece PEARL 8.0; Transmyocardial Laser Revascularization Handpiece SoloGrip III
Classification Name: SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Product Code: MNO
Device Class: 3
Registered Establishment Name: Sterigenics US LLC
Registered Establishment Number: 2011171
Owner/Operator: Sotera Health LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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