Devices

Device Recall Coolief Sinergy Cooled Radiofrequency Kit

Model / Serial
Lot Number M5264D205
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Product Description
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Manufacturer
Halyard Health, Inc
1 Event
- Recall of Device Recall Coolief Sinergy Cooled Radiofrequency Kit

Manufacturer

Halyard Health, Inc

Manufacturer Address
Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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