FDA-Device2024-03-06Class II
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences Corp.
Hazard
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Bahamas, Belgium, Canada, Chile, France, Germany, Greece, Ireland, Israel, Poland, Portugal, Slovenia, South Africa, Spain, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland (the).
Affected count
8906 units
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1201-2024Don't want to check this manually?
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