Devices

Device Recall Surgicutt Bleeding Time Device

Model / Serial
Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including Arizona andTexas. .
Product Description
Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. || The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations.
Manufacturer
ITC-Nexus Dx
1 Event
- Recall of Device Recall Surgicutt Bleeding Time Device

Manufacturer

ITC-Nexus Dx

Manufacturer Address
ITC-Nexus Dx, 23 Nevsky St, Edison NJ 08820-2425
Manufacturer Parent Company (2017)
Samsung Electronics Co., Ltd.
Source
USFDA

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