Devices

Device Recall 13.5 mm x 50 mm BrainPath Sheath

Model / Serial
REF: NN-8011 - LOT: 80344-TD00214 (manufactured on 11-April-2012)
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including MI and Canada
Product Description
13.5 mm x 50 mm BrainPath Sheath || The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
Manufacturer
Nico Corp.
1 Event
- Recall of Device Recall 13.5 mm x 50 mm BrainPath Sheath

Manufacturer

Nico Corp.

Manufacturer Address
Nico Corp., 12263 Bridgewater Rd, Indianapolis IN 46256-9428
Manufacturer Parent Company (2017)
NICO Corp
Source
USFDA

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