Device typeImplantable glucose monitoring system sensor: A sterile device intended to be implanted subcutaneously for continuous monitoring of glucose levels in interstitial fluid, typically for detecting trends and tracking patterns in patients with diabetes mellitus. It is a small, rod-shaped sensor consisting of an electrochemical or optical glucose detector that emits signals which are sent to an externally-worn transmitter (not included) via a wireless connection. It is passively-powered by the transmitter. Dedicated implantation devices (e.g., blunt dissector, cannula) may be included.
FDA categoryIntegrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Device ID00817491024305
Catalog numberFG-7502-00-301
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional