FDA-Device2013-11-13Class II
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.
ITC-Nexus Dx
Hazard
ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose.
Sold states
Nationwide Distribution including Arizona andTexas. .
Affected count
6 boxes (Each box contains 50 Surgicutt Devices plus 55 sheets of Blotting Paper).
Manufactured in
23 Nevsky St, N/A, Edison, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0137-2014Don't want to check this manually?
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