FDA-Device2023-12-13Class II
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Integra LifeSciences Corp.
Hazard
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Sold states
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
Affected count
173 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0498-2024Don't want to check this manually?
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