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Devices
Device Recall NeuroBalloon
Model / Serial
Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
Product Classification
Neurological Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide, Canada, Taiwan and to Integra, Australia.
Product Description
Integra NeuroSciences Implants, NeuroBalloon Catheter, || Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
Manufacturer
Integra LifeSciences Corp
1 Event
Recall of Device Recall NeuroBalloon
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Manufacturer
Integra LifeSciences Corp
Manufacturer Address
Integra LifeSciences Corp, 105 Morgan Ln, Plainsboro NJ 08536-3339
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA
Language
English
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