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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Orbiter ST Extension Cable
Classification Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Product Code: DRF
Device Class: 2
Regulation Number: 870.1220
Medical Specialty: Cardiovascular
Registered Establishment Name: Affinity Medical Technologies
Registered Establishment Number: 2031044
Owner/Operator: Molex Inc
Owner/Operator Number: 10023185
Establishment Operations: Contract Manufacturer
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