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Integra®
INTEGRA NEUROSCIENCES IMPLANT (FRANCE) · Model 901124 · UDI-DI 10381780033202
GYK
Prescription
1
510(k) clearances
15
Adverse events
1
Recalls
21
Facilities
Description
The 61 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of appropriate length (61 cm) during the placement of a peritoneal drainage catheter in the treatment of hydrocephalus. It features a tapered tip to facilitate subcutaneous insertion and passage.
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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Get your free API keyRead the docsData 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.