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gammaCore Sapphire Refill Card Kit

electroCore, Inc. · Model 13016-04501 · UDI-DI 00815203021468

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

Description

gammaCore Sapphire 31-Day Refill Card Kit intended for use with gammaCore Sapphire Devices. gammaCore Sapphire is intended to provide nVNS stimulation on side of neck; indicated for acute treatment of pain associated with episodic cluster headache & migraine headache in adolescent (12 years old and older) and adult patients. The Refill Card Kit is intended to refill / reload the device for a specified number of days or months and doses.

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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.