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Devices
Device Recall Integra Cranial Access Kits
Model / Serial
Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and VA/govt/military. No foreign consignees.
Product Description
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Manufacturer
Integra LifeSciences Corp. d.b.a. Integra Pain Management
1 Event
Recall of Device Recall Integra Cranial Access Kits
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Manufacturer
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Manufacturer Address
Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 W 2400 S Ste 1050, Salt Lake City UT 84119-1135
Manufacturer Parent Company (2017)
Integra LifeSciences Holdings Corporation
Source
USFDA
Language
English
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