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gammaCore Sapphire SLC DEMO Device Kit

electroCore, Inc. · Model 13016-04009 · UDI-DI 00815203021345

PKRQAK Prescription
9
510(k) clearances
1
Adverse events
0
Recalls
1
Facilities

Description

gammaCore Sapphire 36-Month DEMO Device Kit (preprogrammed, refillable) is intended to be used to train HCPs and end users on proper use and the application of nVNS stimulation as indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.