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Integra®

INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 990010 · UDI-DI 10381780034414

GYK JXG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable handle, plastic line with bullet-shaped end and barbed end, and sheath. The tunneler (65 cm) is used to make a subcutaneous tunnel between two incisions for procedures such as the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. The barbed end is intended to be connected to a 0.8 to 1.4 mm internal diameter catheter.

Recalls

Date	Firm	Reason
2010-12-22	Integra LifeSciences Corp.	Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

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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.